FDA letters by response type
Warning Letter FDA Letters
Serious post-market compliance violation. Browse source-linked warning letter records with structured metadata, regulatory context, and document-level summaries.
| Letter | Type | Date | Agency / Product | Status |
|---|---|---|---|---|
Warning Letter The Platinum Healthcare LLC (Oct 1, 2026) FDA issued a warning letter to The Platinum Healthcare LLC concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs | Open |
Warning Letter Bioactive Services USA, LLC / Herstat Inc. (Oct 1, 2026) FDA issued a warning letter to Bioactive Services USA, LLC / Herstat Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs | Open |
Warning Letter DesBio/Deseret Biologicals, Inc. (Oct 1, 2026) FDA issued a warning letter to DesBio/Deseret Biologicals, Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs | Open |
Warning Letter Amazon.com, Inc. (Oct 1, 2026) FDA issued a warning letter to Amazon.com, Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs | Open |
Warning Letter OrganiCare, LLC / OrganiCare Nature’s Science, LLC (Oct 1, 2026) FDA issued a warning letter to OrganiCare, LLC / OrganiCare Nature’s Science, LLC concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs | Open |
Warning Letter Walmart, Inc. (Oct 1, 2026) FDA issued a warning letter to Walmart, Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs | Open |
Warning Letter Aidance Scientific, Inc. (Oct 1, 2026) FDA issued a warning letter to Aidance Scientific, Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs | Open |
Warning Letter Graceful Touch, LLC (Oct 1, 2026) FDA issued a warning letter to Graceful Touch, LLC concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs | Open |
Warning Letter RoyceDerm LLC (Oct 1, 2026) FDA issued a warning letter to RoyceDerm LLC concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs | Open |
Warning Letter Terramed (Oct 1, 2026) FDA issued a warning letter to Terramed concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs | Open |
Warning Letter sfshoply.com (Sep 25, 2026) FDA issued a warning letter to sfshoply.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Cheap Medicine Shop/www.cheapmedicineshop.com (Sep 24, 2026) FDA issued a warning letter to Cheap Medicine Shop/www.cheapmedicineshop.com concerning Unapproved New Drugs/Misbranded (Internet Pharmacy). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded (Internet Pharmacy) | Open |
Warning Letter Online Generic Medicine/www.onlinegenericmedicine.com (Sep 23, 2026) FDA issued a warning letter to Online Generic Medicine/www.onlinegenericmedicine.com concerning Unapproved New Drug/Misbranded (Internet Pharmacy). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drug/Misbranded (Internet Pharmacy) | Open |
Warning Letter Neogen Corporation (Sep 23, 2026) FDA issued a warning letter to Neogen Corporation concerning CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Open |
Warning Letter Sciarra Aeromed, Inc. (Sep 23, 2026) FDA issued a warning letter to Sciarra Aeromed, Inc. concerning CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Open |
Warning Letter Fresenius Kabi USA LLC (Sep 22, 2026) FDA issued a warning letter to Fresenius Kabi USA LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Unilam Co., LTD (Sep 22, 2026) FDA issued a warning letter to Unilam Co., LTD concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Medical device quality and reporting, Quality systems and CAPA, Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/Adulterated | Open |
Warning Letter Babikian Healthcare Products CJSC (Sep 21, 2026) FDA issued a warning letter to Babikian Healthcare Products CJSC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Empower Clinic Services, LLC dba Empower Pharmacy (Sep 18, 2026) FDA issued a warning letter to Empower Clinic Services, LLC dba Empower Pharmacy concerning CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Data integrity and records, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | Open |
Warning Letter Curia New York, Inc. (Sep 18, 2026) FDA issued a warning letter to Curia New York, Inc. concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Data integrity and records, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Open |
Warning Letter Bentley Laboratories LLC (Sep 17, 2026) FDA issued a warning letter to Bentley Laboratories LLC concerning CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Open |
Warning Letter Celmade (Sep 14, 2026) FDA issued a warning letter to Celmade concerning Review of Website/Unapproved New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Review of Website/Unapproved New Drug/Misbranded | Open |
Warning Letter NexCell Scientific Inc (Sep 11, 2026) FDA issued a warning letter to NexCell Scientific Inc concerning Unapproved New Drugs/Unlicensed Biological Product Violations. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Unapproved products and premarket authorization, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Unlicensed Biological Product Violations | Open |
Warning Letter kdc/one Chatsworth, Inc. (Sep 8, 2026) FDA issued a warning letter to kdc/one Chatsworth, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Laboratory controls and testing, Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Bausch & Lomb Inc. (Sep 4, 2026) FDA issued a warning letter to Bausch & Lomb Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter TCI Co., Ltd BioCosme PABP BRANCH (Sep 2, 2026) FDA issued a warning letter to TCI Co., Ltd BioCosme PABP BRANCH concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Star Ocean Wholesale Foods, Inc. (Sep 1, 2026) FDA issued a warning letter to Star Ocean Wholesale Foods, Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Open |
Warning Letter O.N. Diagnostics, LLC (Sep 1, 2026) FDA issued a warning letter to O.N. Diagnostics, LLC concerning Medical Device Reporting/Misbranded. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Medical Device Reporting/Misbranded | Open |
Warning Letter Happy Farm Botanicals, Inc. (Sep 1, 2026) FDA issued a warning letter to Happy Farm Botanicals, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Tipical Latin Food, Corp. DBA La Pradera (Aug 28, 2026) FDA issued a warning letter to Tipical Latin Food, Corp. DBA La Pradera concerning CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | Open |
Warning Letter Stephen J. Fallon, Ph.D. (Aug 27, 2026) FDA issued a warning letter to Stephen J. Fallon, Ph.D. concerning Bioresearch Monitoring Program/Institutional Review Board (IRB). Deterministic full-text screening identifies discussion of Clinical research and human-subject protections. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Bioresearch Monitoring Program/Institutional Review Board (IRB) | Open |
Warning Letter Union Trade Inc. (Aug 27, 2026) FDA issued a warning letter to Union Trade Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Jabil Inc. (Aug 27, 2026) FDA issued a warning letter to Jabil Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Andrighetto Produce Inc dba Shasta Produce Inc (Aug 27, 2026) FDA issued a warning letter to Andrighetto Produce Inc dba Shasta Produce Inc concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Fresenius Medical Care AG & Co. KGaA (Aug 25, 2026) FDA issued a warning letter to Fresenius Medical Care AG & Co. KGaA concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Advance-Esthetic LLC (Aug 25, 2026) FDA issued a warning letter to Advance-Esthetic LLC concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | Open |
Warning Letter Peptide Partners LLC (Aug 24, 2026) FDA issued a warning letter to Peptide Partners LLC concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter BioDrive, Inc. (Aug 24, 2026) FDA issued a warning letter to BioDrive, Inc. concerning Dietary Supplement/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Dietary Supplement/Adulterated | Open |
Warning Letter Royal Peptides LLC (Aug 24, 2026) FDA issued a warning letter to Royal Peptides LLC concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Peak Performance Peptides (Aug 24, 2026) FDA issued a warning letter to Peak Performance Peptides concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter TXP Innovations LLC dba Tex Peptides (Aug 24, 2026) FDA issued a warning letter to TXP Innovations LLC dba Tex Peptides concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter NuScience Peptides LLC (Aug 24, 2026) FDA issued a warning letter to NuScience Peptides LLC concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Lion Street Medical, d/b/a Pensar Medical LLC (Aug 21, 2026) FDA issued a warning letter to Lion Street Medical, d/b/a Pensar Medical LLC concerning Medical Device Reporting/Misbranded. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Medical Device Reporting/Misbranded | Open |
Warning Letter Raaw Energy LLC (Aug 21, 2026) FDA issued a warning letter to Raaw Energy LLC concerning Adulterated Animal Foods/Misbranded. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Adulterated Animal Foods/Misbranded | Open |
Warning Letter South Asian Food Inc. (Aug 20, 2026) FDA issued a warning letter to South Asian Food Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Open |
Warning Letter B&P Mutual Corp (Aug 18, 2026) FDA issued a warning letter to B&P Mutual Corp concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Shoolin Pharma Chem LLP (Aug 18, 2026) FDA issued a warning letter to Shoolin Pharma Chem LLP concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Data integrity and records, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Open |
Warning Letter Binh Minh Tofu (Aug 18, 2026) FDA issued a warning letter to Binh Minh Tofu concerning CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated | Open |
Warning Letter PReye, LLC (Aug 18, 2026) FDA issued a warning letter to PReye, LLC concerning CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Unapproved products and premarket authorization, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | Open |
Warning Letter Reliance Life Sciences Private Limited (Aug 18, 2026) FDA issued a warning letter to Reliance Life Sciences Private Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Importaciones La Bufa LLC (Aug 17, 2026) FDA issued a warning letter to Importaciones La Bufa LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter R3 Medical Companies (Aug 14, 2026) FDA issued a warning letter to R3 Medical Companies concerning Unapproved New Drugs/Unlicensed Biological Product Violations. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Unlicensed Biological Product Violations | Open |
Warning Letter Suretec Innovations, LLC (Aug 13, 2026) FDA issued a warning letter to Suretec Innovations, LLC concerning CGMP/Finished Pharmaceuticals/Adulterated and Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated and Misbranded | Open |
Warning Letter Eugia Pharma Specialities Limited (Aug 13, 2026) FDA issued a warning letter to Eugia Pharma Specialities Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Bo Wah Enterprises Inc (Aug 13, 2026) FDA issued a warning letter to Bo Wah Enterprises Inc concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Auriga Research Pvt. Ltd. (Aug 12, 2026) FDA issued a warning letter to Auriga Research Pvt. Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter K.C. Pharmaceuticals, Inc. (Aug 12, 2026) FDA issued a warning letter to K.C. Pharmaceuticals, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Safrel Pharmaceuticals LLC (Aug 7, 2026) FDA issued a warning letter to Safrel Pharmaceuticals LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Pine Pharmaceuticals, LLC (Aug 7, 2026) FDA issued a warning letter to Pine Pharmaceuticals, LLC concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Compounding Pharmacy/Adulterated Drug Products | Open |
Warning Letter giantnic.com (Aug 7, 2026) FDA issued a warning letter to giantnic.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter mikuvape.com (Aug 7, 2026) FDA issued a warning letter to mikuvape.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. (Aug 6, 2026) FDA issued a warning letter to Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded | Open |
Warning Letter Viva Raw LLC (Aug 5, 2026) FDA issued a warning letter to Viva Raw LLC concerning Adulterated Animal Foods/Misbranded. Deterministic full-text screening identifies discussion of Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Adulterated Animal Foods/Misbranded | Open |
Warning Letter Quantum Star LLC (Aug 5, 2026) FDA issued a warning letter to Quantum Star LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Mesquite Gourmet LLC (Aug 4, 2026) FDA issued a warning letter to Mesquite Gourmet LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Stokes Healthcare Inc. dba Epicur Pharma (Aug 4, 2026) FDA issued a warning letter to Stokes Healthcare Inc. dba Epicur Pharma concerning Animal Drugs/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Animal Drugs/Adulterated | Open |
Warning Letter American Pharma Mfg. Inc. (Aug 4, 2026) FDA issued a warning letter to American Pharma Mfg. Inc. concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Dietary Supplement/Adulterated/Misbranded | Open |
Warning Letter H2 BEV, LLC and H2 RENU, INC (Jul 31, 2026) FDA issued a warning letter to H2 BEV, LLC and H2 RENU, INC concerning Acidified Foods/Emergency Permit Control/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Acidified Foods/Emergency Permit Control/Adulterated/Misbranded | Open |
Warning Letter FairyGene, Inc. (Jul 31, 2026) FDA issued a warning letter to FairyGene, Inc. concerning CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Quality systems and CAPA, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Open |
Warning Letter Lico Industries, LLC., d.b.a. American Towelette Company (Jul 30, 2026) FDA issued a warning letter to Lico Industries, LLC., d.b.a. American Towelette Company concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Data integrity and records, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter DeJong Family Dairy, LLC (Jul 30, 2026) FDA issued a warning letter to DeJong Family Dairy, LLC concerning New Animal Drug/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA New Animal Drug/Adulterated | Open |
Warning Letter Maria E. De La Torre Silva, M.D. (Jul 27, 2026) FDA issued a warning letter to Maria E. De La Torre Silva, M.D. concerning Clinical Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Data integrity and records, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Clinical Investigator | Open |
Warning Letter Vargas Produce LLC (Jul 27, 2026) FDA issued a warning letter to Vargas Produce LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Woodbine Products Company Inc. (Jul 27, 2026) FDA issued a warning letter to Woodbine Products Company Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Nipro Renal Solutions USA, Corporation (Jul 24, 2026) FDA issued a warning letter to Nipro Renal Solutions USA, Corporation concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding, Medical device quality and reporting. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/Adulterated | Open |
Warning Letter Dabur India Limited (Jul 24, 2026) FDA issued a warning letter to Dabur India Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Thomas Brunner Hygiene GmbH (Jul 24, 2026) FDA issued a warning letter to Thomas Brunner Hygiene GmbH concerning CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Quality systems and CAPA, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Open |
Warning Letter Wilson Livestock (Jul 24, 2026) FDA issued a warning letter to Wilson Livestock concerning New Animal Drug/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA New Animal Drug/Adulterated | Open |
Warning Letter Eherbs Imports, Inc (Jul 23, 2026) FDA issued a warning letter to Eherbs Imports, Inc concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter ABS Corporation (Jul 23, 2026) FDA issued a warning letter to ABS Corporation concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Laboratory controls and testing, Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Ohom Padmaavathii, LLC (Jul 22, 2026) FDA issued a warning letter to Ohom Padmaavathii, LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Koven Technologies, Inc. (Jul 21, 2026) FDA issued a warning letter to Koven Technologies, Inc. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Quality systems and CAPA, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/Adulterated | Open |
Warning Letter Fil-Bay Import, Inc. (Jul 20, 2026) FDA issued a warning letter to Fil-Bay Import, Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter mkpodplug.co.uk (Jul 17, 2026) FDA issued a warning letter to mkpodplug.co.uk concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter San Jorge Produce LLC (Jul 16, 2026) FDA issued a warning letter to San Jorge Produce LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Island Kinetics, Inc. d.b.a. CoValence Laboratories (Jul 16, 2026) FDA issued a warning letter to Island Kinetics, Inc. d.b.a. CoValence Laboratories concerning CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Labeling, claims, and misbranding, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | Open |
Warning Letter LDNN Produce Inc. (Jul 15, 2026) FDA issued a warning letter to LDNN Produce Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter AAL Trading Inc. (Jul 15, 2026) FDA issued a warning letter to AAL Trading Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Friend’s Stable and Orchard, Inc. (Jul 14, 2026) FDA issued a warning letter to Friend’s Stable and Orchard, Inc. concerning Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated | Open |
Warning Letter BioMylz Pvt. Ltd. (Jul 13, 2026) FDA issued a warning letter to BioMylz Pvt. Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | Open |
Warning Letter Almon Healthcare Private Limited (Jul 13, 2026) FDA issued a warning letter to Almon Healthcare Private Limited concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Open |
Warning Letter Shimoga Chemicals (Jul 13, 2026) FDA issued a warning letter to Shimoga Chemicals concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Data integrity and records, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Open |
Warning Letter indejuicevapestore.co.uk (Jul 10, 2026) FDA issued a warning letter to indejuicevapestore.co.uk concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. (Jul 10, 2026) FDA issued a warning letter to Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. concerning In Vivo Bioavailability-Bioequivalence Studies – Clinical. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA In Vivo Bioavailability-Bioequivalence Studies – Clinical | Open |
Warning Letter ejuicedemand.com (Jul 10, 2026) FDA issued a warning letter to ejuicedemand.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter VasoCorp, Inc. (Jul 9, 2026) FDA issued a warning letter to VasoCorp, Inc. concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Beauty Store LLC (Jul 8, 2026) FDA issued a warning letter to Beauty Store LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Spa De Soleil, Inc. (Jul 8, 2026) FDA issued a warning letter to Spa De Soleil, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter IJAJ Group Inc DBA Sanz Wholesale Foods (Jul 8, 2026) FDA issued a warning letter to IJAJ Group Inc DBA Sanz Wholesale Foods concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Specialty Health Products CO, LLC (Jul 7, 2026) FDA issued a warning letter to Specialty Health Products CO, LLC concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Labeling, claims, and misbranding, Medical device quality and reporting, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/Adulterated | Open |
Warning Letter Waves and Wine, Inc. (Jul 6, 2026) FDA issued a warning letter to Waves and Wine, Inc. concerning CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated | Open |
Warning Letter International Medication Systems Limited (Jul 2, 2026) FDA issued a warning letter to International Medication Systems Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter eliquidflavourconcentrates.co.uk (Jul 2, 2026) FDA issued a warning letter to eliquidflavourconcentrates.co.uk concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Good Stuff Cacao (Jul 2, 2026) FDA issued a warning letter to Good Stuff Cacao concerning New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA New Drug/Misbranded | Open |
Warning Letter snusblast.co.uk (Jul 2, 2026) FDA issued a warning letter to snusblast.co.uk concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Piquin Y Sabores Distributors LLC (Jul 2, 2026) FDA issued a warning letter to Piquin Y Sabores Distributors LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Balkanica LLC (Jun 29, 2026) FDA issued a warning letter to Balkanica LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Shouly Import Corp. (Jun 26, 2026) FDA issued a warning letter to Shouly Import Corp. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Excelvision - Fareva (Jun 25, 2026) FDA issued a warning letter to Excelvision - Fareva concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Wizcure Pharmaa Private Limited (Jun 24, 2026) FDA issued a warning letter to Wizcure Pharmaa Private Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Data integrity and records, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Win Woo Trading, LLC / HF Foods Group (Jun 24, 2026) FDA issued a warning letter to Win Woo Trading, LLC / HF Foods Group concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter LyfeUnit / www.lyfeunit.com (Jun 23, 2026) FDA issued a warning letter to LyfeUnit / www.lyfeunit.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Ketamine Troche Store / www.ketaminetrochestore.com (Jun 23, 2026) FDA issued a warning letter to Ketamine Troche Store / www.ketaminetrochestore.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com (Jun 23, 2026) FDA issued a warning letter to Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Med Shop Inc / www.medshopinc.com (Jun 23, 2026) FDA issued a warning letter to Med Shop Inc / www.medshopinc.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Allandale Dairy (Jun 23, 2026) FDA issued a warning letter to Allandale Dairy concerning New Animal Drug/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA New Animal Drug/Adulterated | Open |
Warning Letter Keta Med Lab / www.ketamedlab.com (Jun 23, 2026) FDA issued a warning letter to Keta Med Lab / www.ketamedlab.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Legit Ketamine Suppliers / www.legitketaminesuppliers.com (Jun 23, 2026) FDA issued a warning letter to Legit Ketamine Suppliers / www.legitketaminesuppliers.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Extra Medication / www.extramedication.com (Jun 23, 2026) FDA issued a warning letter to Extra Medication / www.extramedication.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Ketacyn Pharmaceuticals / www.ketacynpharma.com (Jun 23, 2026) FDA issued a warning letter to Ketacyn Pharmaceuticals / www.ketacynpharma.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter ketaminetroches.com (Jun 23, 2026) FDA issued a warning letter to ketaminetroches.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Ketdaxandrugs / www.ketdaxandrugs.org (Jun 23, 2026) FDA issued a warning letter to Ketdaxandrugs / www.ketdaxandrugs.org concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Ket Plug / ketaminelab.org and buyketaminepowderonline.com (Jun 23, 2026) FDA issued a warning letter to Ket Plug / ketaminelab.org and buyketaminepowderonline.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Buy Keta Online / www.buyketaonline.com (Jun 23, 2026) FDA issued a warning letter to Buy Keta Online / www.buyketaonline.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter All Ketamine HCL / www.allketaminehcl.com (Jun 23, 2026) FDA issued a warning letter to All Ketamine HCL / www.allketaminehcl.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Ketamine Store / www.ketaminestore.org (Jun 23, 2026) FDA issued a warning letter to Ketamine Store / www.ketaminestore.org concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Genzyme Ireland Limited (Jun 22, 2026) FDA issued a warning letter to Genzyme Ireland Limited concerning CGMP/Deviations/Biologics License Application (BLA). Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Deviations/Biologics License Application (BLA) | Open |
Warning Letter Texinkart Inc. (Jun 17, 2026) FDA issued a warning letter to Texinkart Inc. concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Herbal Dermals LLC FZ dba Gotucream (Jun 17, 2026) FDA issued a warning letter to Herbal Dermals LLC FZ dba Gotucream concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Hadassah Healing Oils Ltd (Jun 17, 2026) FDA issued a warning letter to Hadassah Healing Oils Ltd concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs | Open |
Warning Letter Telos Trading Limited dba Alwinshop (Jun 17, 2026) FDA issued a warning letter to Telos Trading Limited dba Alwinshop concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Leading Edge Health Inc. (Jun 17, 2026) FDA issued a warning letter to Leading Edge Health Inc. concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Amazon.com, Inc. (Jun 17, 2026) FDA issued a warning letter to Amazon.com, Inc. concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Wild Arabic Herbs (Jun 17, 2026) FDA issued a warning letter to Wild Arabic Herbs concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Indiangoods.shop (Jun 17, 2026) FDA issued a warning letter to Indiangoods.shop concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Great India Overseas Pvt. Ltd. dba Silkrute (Jun 17, 2026) FDA issued a warning letter to Great India Overseas Pvt. Ltd. dba Silkrute concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs | Open |
Warning Letter Wholesale Peptide (Jun 17, 2026) FDA issued a warning letter to Wholesale Peptide concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter MantroForce (Jun 17, 2026) FDA issued a warning letter to MantroForce concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter JJLBRO (Jun 17, 2026) FDA issued a warning letter to JJLBRO concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Diamond Distributions LLC (Jun 16, 2026) FDA issued a warning letter to Diamond Distributions LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Tex-Stein Dairy (Jun 16, 2026) FDA issued a warning letter to Tex-Stein Dairy concerning New Animal Drug/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA New Animal Drug/Adulterated | Open |
Warning Letter Life & Food Inc. (Jun 15, 2026) FDA issued a warning letter to Life & Food Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Happiest Baby, Inc. (Jun 15, 2026) FDA issued a warning letter to Happiest Baby, Inc. concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | Open |
Warning Letter Huons Co., Ltd. (Jun 15, 2026) FDA issued a warning letter to Huons Co., Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Yangzhou Hongshengding Chemical Co., Ltd. (Jun 15, 2026) FDA issued a warning letter to Yangzhou Hongshengding Chemical Co., Ltd. concerning Refusal to Provide Access to and Copying of Records. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Refusal to Provide Access to and Copying of Records | Open |
Warning Letter AHC Products, Inc. (Jun 12, 2026) FDA issued a warning letter to AHC Products, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Labeling, claims, and misbranding, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Nihon Kohden Digital Health Solutions, LLC (Jun 12, 2026) FDA issued a warning letter to Nihon Kohden Digital Health Solutions, LLC concerning Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | Open |
Warning Letter Maximus Health, Inc. dba Maximus (Jun 8, 2026) FDA issued a warning letter to Maximus Health, Inc. dba Maximus concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Medica Weight Loss (Jun 8, 2026) FDA issued a warning letter to Medica Weight Loss concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter HydraMed IV LLC dba HydraMed (Jun 8, 2026) FDA issued a warning letter to HydraMed IV LLC dba HydraMed concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter FITISH (Jun 8, 2026) FDA issued a warning letter to FITISH concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Momentum Health 360 dba Momentum Health (Jun 8, 2026) FDA issued a warning letter to Momentum Health 360 dba Momentum Health concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Ezra Holdco LLC dba Ezra (Jun 8, 2026) FDA issued a warning letter to Ezra Holdco LLC dba Ezra concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Nova Vascular LLC dba NOVARX (Jun 8, 2026) FDA issued a warning letter to Nova Vascular LLC dba NOVARX concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter NativeMed LLC dba NativeMed (Jun 8, 2026) FDA issued a warning letter to NativeMed LLC dba NativeMed concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Delight Distribution Inc. (Jun 8, 2026) FDA issued a warning letter to Delight Distribution Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter OrderlyMeds LLC dba OrderlyMeds (Jun 8, 2026) FDA issued a warning letter to OrderlyMeds LLC dba OrderlyMeds concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Eden Health International Inc. dba Eden (Jun 8, 2026) FDA issued a warning letter to Eden Health International Inc. dba Eden concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter D&H Medical Services (Jun 8, 2026) FDA issued a warning letter to D&H Medical Services concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Roen Health, Inc. dba RoenRx (Jun 8, 2026) FDA issued a warning letter to Roen Health, Inc. dba RoenRx concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Trinity HealthCare Supply, LLC dba altRx (Jun 8, 2026) FDA issued a warning letter to Trinity HealthCare Supply, LLC dba altRx concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Vivot LLC (Jun 8, 2026) FDA issued a warning letter to Vivot LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Altru Telehealth, LLC dba Altru Telehealth (Jun 8, 2026) FDA issued a warning letter to Altru Telehealth, LLC dba Altru Telehealth concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Nexlife Inc. dba Nexlife (Jun 8, 2026) FDA issued a warning letter to Nexlife Inc. dba Nexlife concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Public Health Solution LLC dba DrMedHealth (Jun 8, 2026) FDA issued a warning letter to Public Health Solution LLC dba DrMedHealth concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter VivioMD Group LLC dba VivioMD (Jun 8, 2026) FDA issued a warning letter to VivioMD Group LLC dba VivioMD concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Ready Med (Jun 8, 2026) FDA issued a warning letter to Ready Med concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Joi and Blokes dba Joi + Blokes (Jun 8, 2026) FDA issued a warning letter to Joi and Blokes dba Joi + Blokes concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Amie Health, Inc. dba Amie (Jun 8, 2026) FDA issued a warning letter to Amie Health, Inc. dba Amie concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Nexus Health Solutions LLC dba Harper Meds (Jun 8, 2026) FDA issued a warning letter to Nexus Health Solutions LLC dba Harper Meds concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Clover Meds LLC dba Clover Meds (Jun 8, 2026) FDA issued a warning letter to Clover Meds LLC dba Clover Meds concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter FitRX, LLC dba AM RX (Jun 8, 2026) FDA issued a warning letter to FitRX, LLC dba AM RX concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter YS Group Inc. (Jun 8, 2026) FDA issued a warning letter to YS Group Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Thrivelab Co. dba Thrivelab (Jun 8, 2026) FDA issued a warning letter to Thrivelab Co. dba Thrivelab concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Glow Medispa, LLC dba Mint Med (Jun 8, 2026) FDA issued a warning letter to Glow Medispa, LLC dba Mint Med concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Imu-Tek Animal Health, Incorporated (Jun 5, 2026) FDA issued a warning letter to Imu-Tek Animal Health, Incorporated concerning Dietary Supplement/New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Dietary Supplement/New Drug/Misbranded | Open |
Warning Letter Mineral BioSciences, LLC (Jun 5, 2026) FDA issued a warning letter to Mineral BioSciences, LLC concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Sante Manufacturing Inc. (Jun 5, 2026) FDA issued a warning letter to Sante Manufacturing Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter AseptiKits, LLC (Jun 4, 2026) FDA issued a warning letter to AseptiKits, LLC concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | Open |
Warning Letter Nutratech, LLC (Jun 4, 2026) FDA issued a warning letter to Nutratech, LLC concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Dietary Supplement/Adulterated/Misbranded | Open |
Warning Letter BlephEx, LLC (Jun 3, 2026) FDA issued a warning letter to BlephEx, LLC concerning Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). Deterministic full-text screening identifies discussion of Quality systems and CAPA, Labeling, claims, and misbranding, Medical device quality and reporting, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | Open |
Warning Letter Hubei Gedian Humanwell Pharmaceutical Co., Ltd. (Jun 3, 2026) FDA issued a warning letter to Hubei Gedian Humanwell Pharmaceutical Co., Ltd. concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Open |
Warning Letter InvaDerm, Inc. (Jun 3, 2026) FDA issued a warning letter to InvaDerm, Inc. concerning Electronic Drug Registration and Listing System (eDRLS)/Violations. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Electronic Drug Registration and Listing System (eDRLS)/Violations | Open |
Warning Letter M G R Produce LLC (Jun 2, 2026) FDA issued a warning letter to M G R Produce LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter PLZ Corp (Jun 2, 2026) FDA issued a warning letter to PLZ Corp concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/OTC Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Gopaldas Visram & Co., Ltd. (Jun 2, 2026) FDA issued a warning letter to Gopaldas Visram & Co., Ltd. concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Quality systems and CAPA, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/OTC Finished Pharmaceuticals/Adulterated | Open |
Warning Letter SL Follen Company (Jun 2, 2026) FDA issued a warning letter to SL Follen Company concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Zydus Lifesciences Limited (Jun 2, 2026) FDA issued a warning letter to Zydus Lifesciences Limited concerning Request for Records/CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Request for Records/CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Umendra Life Sciences Private Limited (Jun 2, 2026) FDA issued a warning letter to Umendra Life Sciences Private Limited concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/OTC Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Shantou Qiwei Industry Co., LTD (Jun 2, 2026) FDA issued a warning letter to Shantou Qiwei Industry Co., LTD concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/OTC Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Erkul Kozmetik Sanayi ve Ticaret A.S. (Jun 2, 2026) FDA issued a warning letter to Erkul Kozmetik Sanayi ve Ticaret A.S. concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/OTC Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Revlon Group Holdings, LLC (Jun 2, 2026) FDA issued a warning letter to Revlon Group Holdings, LLC concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/OTC Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Laboratorios Dr. Collado S.A. (Jun 2, 2026) FDA issued a warning letter to Laboratorios Dr. Collado S.A. concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/OTC Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Asanuma Corporation - Sagamihara Factory (Jun 2, 2026) FDA issued a warning letter to Asanuma Corporation - Sagamihara Factory concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/OTC Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Yam Man Foods LLC (Jun 1, 2026) FDA issued a warning letter to Yam Man Foods LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Macau-Union Pharmaceutical Limited (May 29, 2026) FDA issued a warning letter to Macau-Union Pharmaceutical Limited concerning Nonprescription/OTC. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Nonprescription/OTC | Open |
Warning Letter Jubilant HollisterStier General Partnership (May 28, 2026) FDA issued a warning letter to Jubilant HollisterStier General Partnership concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Medline Inc (May 28, 2026) FDA issued a warning letter to Medline Inc concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Jose M. Carpio, M.D. (May 28, 2026) FDA issued a warning letter to Jose M. Carpio, M.D. concerning Clinical Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Clinical Investigator | Open |
Warning Letter Pharmathen International S.A. (May 27, 2026) FDA issued a warning letter to Pharmathen International S.A. concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Open |
Warning Letter Linemaster Switch Corporation (May 27, 2026) FDA issued a warning letter to Linemaster Switch Corporation concerning CGMP/QSR/Drug/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Drug/Medical Devices/Adulterated | Open |
Warning Letter AF Import & Wholesale Co (May 26, 2026) FDA issued a warning letter to AF Import & Wholesale Co concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Open |
Warning Letter Blue Horizon International, LLC (May 26, 2026) FDA issued a warning letter to Blue Horizon International, LLC concerning Unapproved New Drugs/Unlicensed Biological Product Violations. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Unlicensed Biological Product Violations | Open |
Warning Letter Pamex Foods Incorporated (May 26, 2026) FDA issued a warning letter to Pamex Foods Incorporated concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter ZIIP, Inc. (May 22, 2026) FDA issued a warning letter to ZIIP, Inc. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Labeling, claims, and misbranding, Medical device quality and reporting, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/Adulterated | Open |
Warning Letter Laboratorios Jaloma S.A. de C.V. (May 22, 2026) FDA issued a warning letter to Laboratorios Jaloma S.A. de C.V. concerning CGMP/OTC/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/OTC/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Aeroflex Industria de Aerosol Ltda. (May 22, 2026) FDA issued a warning letter to Aeroflex Industria de Aerosol Ltda. concerning Refusal to Provide Access to and Copying of Records. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Refusal to Provide Access to and Copying of Records | Open |
Warning Letter Alchymars ICM SM Private Limited (May 21, 2026) FDA issued a warning letter to Alchymars ICM SM Private Limited concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Open |
Warning Letter BMC Medical Co., Ltd. (May 20, 2026) FDA issued a warning letter to BMC Medical Co., Ltd. concerning CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Unapproved products and premarket authorization, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | Open |
Warning Letter Aversa's Italian Bakery (May 20, 2026) FDA issued a warning letter to Aversa's Italian Bakery concerning CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Food safety and supplier verification, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated | Open |
Warning Letter Golden Dakota Farms LLC (May 20, 2026) FDA issued a warning letter to Golden Dakota Farms LLC concerning New Animal Drug/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA New Animal Drug/Adulterated | Open |
Warning Letter 3B Medical, Inc. dba Reach Health, Inc. (May 20, 2026) FDA issued a warning letter to 3B Medical, Inc. dba Reach Health, Inc. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/Adulterated | Open |
Warning Letter vapetrinity.com (May 19, 2026) FDA issued a warning letter to vapetrinity.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter HealthPartners Neuroscience Center Research and Innovation (May 19, 2026) FDA issued a warning letter to HealthPartners Neuroscience Center Research and Innovation concerning Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. Deterministic full-text screening identifies discussion of Data integrity and records, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | Open |
Warning Letter snusguys.com (May 19, 2026) FDA issued a warning letter to snusguys.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter npouches.com (May 19, 2026) FDA issued a warning letter to npouches.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter pouchline.com (May 19, 2026) FDA issued a warning letter to pouchline.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Skytron, LLC (May 19, 2026) FDA issued a warning letter to Skytron, LLC concerning Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | Open |
Warning Letter pouchew.com (May 19, 2026) FDA issued a warning letter to pouchew.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Smoker Business (May 19, 2026) FDA issued a warning letter to Smoker Business concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter vapenovaco.com (May 19, 2026) FDA issued a warning letter to vapenovaco.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter gethyppe.com (May 19, 2026) FDA issued a warning letter to gethyppe.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter GSC Products, LLC (May 18, 2026) FDA issued a warning letter to GSC Products, LLC concerning Nonprescription/OTC. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Nonprescription/OTC | Open |
Warning Letter Sato Pharmaceutical Co., Ltd. (May 18, 2026) FDA issued a warning letter to Sato Pharmaceutical Co., Ltd. concerning CGMP/Drugs/Adulterated/OTC. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Drugs/Adulterated/OTC | Open |
Warning Letter Aja Health and Wellness Inc. (May 18, 2026) FDA issued a warning letter to Aja Health and Wellness Inc. concerning Nonprescription/OTC. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Nonprescription/OTC | Open |
Warning Letter vape4sale.com (May 15, 2026) FDA issued a warning letter to vape4sale.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Meta Labs Pharmaceuticals, LLC (May 15, 2026) FDA issued a warning letter to Meta Labs Pharmaceuticals, LLC concerning Dietary Supplement/New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Dietary Supplement/New Drug/Misbranded | Open |
Warning Letter City Market, Inc. (May 15, 2026) FDA issued a warning letter to City Market, Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Open |
Warning Letter La Crema De Rebeca (May 14, 2026) FDA issued a warning letter to La Crema De Rebeca concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Bharat Overseas Inc. (May 14, 2026) FDA issued a warning letter to Bharat Overseas Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter GC America, Inc. (May 14, 2026) FDA issued a warning letter to GC America, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter PolleyMed, LLC (May 14, 2026) FDA issued a warning letter to PolleyMed, LLC concerning Nonprescription/OTC. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Nonprescription/OTC | Open |
Warning Letter Lus Essentials LLC (May 14, 2026) FDA issued a warning letter to Lus Essentials LLC concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Bushman Organic Farms, Inc. (May 14, 2026) FDA issued a warning letter to Bushman Organic Farms, Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Dough-To-Go, Inc. (May 12, 2026) FDA issued a warning letter to Dough-To-Go, Inc. concerning CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated | Open |
Warning Letter Flax & More Corporation (May 12, 2026) FDA issued a warning letter to Flax & More Corporation concerning CGMP/Dietary Supplement/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Dietary Supplement/Adulterated | Open |
Warning Letter Fagron BV (May 12, 2026) FDA issued a warning letter to Fagron BV concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Compounding Pharmacy/Adulterated Drug Products | Open |
Warning Letter ct-riecig.com (May 8, 2026) FDA issued a warning letter to ct-riecig.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter waterbedsnstuff.com (May 8, 2026) FDA issued a warning letter to waterbedsnstuff.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Naseem A. Jaffrani, M.D. (May 4, 2026) FDA issued a warning letter to Naseem A. Jaffrani, M.D. concerning Clinical Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Clinical Investigator | Open |
Warning Letter IDO Pharm Co., Ltd. (May 4, 2026) FDA issued a warning letter to IDO Pharm Co., Ltd. concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/OTC Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Naveh Pharma LTD/Bigdam Inc. (May 4, 2026) FDA issued a warning letter to Naveh Pharma LTD/Bigdam Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Quality systems and CAPA, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | Open |
Warning Letter Harbin Jixianglong Biotech Co., Ltd. (May 1, 2026) FDA issued a warning letter to Harbin Jixianglong Biotech Co., Ltd. concerning CGMP/API/Adulterated and Misbranded Drugs. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/API/Adulterated and Misbranded Drugs | Open |
Warning Letter kadobarofficial.com (May 1, 2026) FDA issued a warning letter to kadobarofficial.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter swisschlz.com (May 1, 2026) FDA issued a warning letter to swisschlz.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter CareFusion 213, LLC (Apr 30, 2026) FDA issued a warning letter to CareFusion 213, LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Laboratory controls and testing, Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter ZOLL Medical Corporation (Apr 30, 2026) FDA issued a warning letter to ZOLL Medical Corporation concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/Adulterated | Open |
Warning Letter Best Buy Bones, Inc. (Apr 30, 2026) FDA issued a warning letter to Best Buy Bones, Inc. concerning CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated | Open |
Warning Letter OptiHealth Products, Inc. (Apr 29, 2026) FDA issued a warning letter to OptiHealth Products, Inc. concerning New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA New Drug/Misbranded | Open |
Warning Letter Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre (Apr 29, 2026) FDA issued a warning letter to Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre concerning In Vivo Bioavailability-Bioequivalence Studies – Clinical. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA In Vivo Bioavailability-Bioequivalence Studies – Clinical | Open |
Warning Letter Sourav K. Mishra, M.D. / All India Institute of Medical Sciences (Apr 29, 2026) FDA issued a warning letter to Sourav K. Mishra, M.D. / All India Institute of Medical Sciences concerning In Vivo Bioavailability-Bioequivalence Studies – Clinical. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA In Vivo Bioavailability-Bioequivalence Studies – Clinical | Open |
Warning Letter Sahara Enterprise Inc. (Apr 29, 2026) FDA issued a warning letter to Sahara Enterprise Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Shineluck Foods, Inc. (Apr 29, 2026) FDA issued a warning letter to Shineluck Foods, Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | Open |
Warning Letter Greenworld Food Express LLC (Apr 24, 2026) FDA issued a warning letter to Greenworld Food Express LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter vibepixi.com (Apr 24, 2026) FDA issued a warning letter to vibepixi.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Ray’s Vitamins (Apr 24, 2026) FDA issued a warning letter to Ray’s Vitamins concerning Unapproved New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drug/Misbranded | Open |
Warning Letter ibeautistore.com (Apr 24, 2026) FDA issued a warning letter to ibeautistore.com concerning Unapproved New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drug/Misbranded | Open |
Warning Letter Great One Trading Inc. (Apr 24, 2026) FDA issued a warning letter to Great One Trading Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Global Imports Origins (Apr 23, 2026) FDA issued a warning letter to Global Imports Origins concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter jadepouch.com (Apr 23, 2026) FDA issued a warning letter to jadepouch.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Minh Phung, Inc. (Apr 22, 2026) FDA issued a warning letter to Minh Phung, Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Food safety and supplier verification, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Open |
Warning Letter Active Cosmetics Manufacturing Inc. (Apr 22, 2026) FDA issued a warning letter to Active Cosmetics Manufacturing Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Laboratory controls and testing, Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Estar Technologies Ltd (Apr 22, 2026) FDA issued a warning letter to Estar Technologies Ltd concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | Open |
Warning Letter Boba Factory Inc (Apr 22, 2026) FDA issued a warning letter to Boba Factory Inc concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Daily Manufacturing Solutions Inc. (Apr 21, 2026) FDA issued a warning letter to Daily Manufacturing Solutions Inc. concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Wellmill, LLC dba Vitamix Laboratories (Apr 20, 2026) FDA issued a warning letter to Wellmill, LLC dba Vitamix Laboratories concerning Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Open |
Warning Letter Foshan Miwei Cosmetics Co., Ltd. (Apr 20, 2026) FDA issued a warning letter to Foshan Miwei Cosmetics Co., Ltd. concerning Nonprescription/OTC. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Nonprescription/OTC | Open |
Warning Letter Respilon Production S.R.O. (Apr 20, 2026) FDA issued a warning letter to Respilon Production S.R.O. concerning CGMP/OTC/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/OTC/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter SaNOtize (Apr 17, 2026) FDA issued a warning letter to SaNOtize concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs | Open |
Warning Letter nicoprof.com (Apr 17, 2026) FDA issued a warning letter to nicoprof.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Great Enterprise - Group - Inc. (Apr 17, 2026) FDA issued a warning letter to Great Enterprise - Group - Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Par Health USA, LLC & Endo USA, Inc. (Apr 15, 2026) FDA issued a warning letter to Par Health USA, LLC & Endo USA, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Hangzhou Yiqi Biotechnology Co., Ltd (Apr 15, 2026) FDA issued a warning letter to Hangzhou Yiqi Biotechnology Co., Ltd concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Open |
Warning Letter Unetixs Vascular, Inc. (Apr 15, 2026) FDA issued a warning letter to Unetixs Vascular, Inc. concerning Premarket Approval/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Quality systems and CAPA, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Premarket Approval/Adulterated | Open |
Warning Letter Stavis Seafoods, LLC (Apr 15, 2026) FDA issued a warning letter to Stavis Seafoods, LLC concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Open |
Warning Letter JW Nutritional LLC (Apr 15, 2026) FDA issued a warning letter to JW Nutritional LLC concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/OTC Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Pro Numb Tattoo Numbing Spray, LLC (Apr 14, 2026) FDA issued a warning letter to Pro Numb Tattoo Numbing Spray, LLC concerning Nonprescription/OTC. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Nonprescription/OTC | Open |
Warning Letter New Life Pharma LLC (Apr 14, 2026) FDA issued a warning letter to New Life Pharma LLC concerning CGMP/Adulterated and Unapproved New Drug/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Adulterated and Unapproved New Drug/Misbranded | Open |
Warning Letter Ava Inc. (Apr 14, 2026) FDA issued a warning letter to Ava Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Data integrity and records, Manufacturing and CGMP controls, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter UCSF Radiopharmaceutical Facility (Apr 13, 2026) FDA issued a warning letter to UCSF Radiopharmaceutical Facility concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter shopcalismokes.com (Apr 10, 2026) FDA issued a warning letter to shopcalismokes.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Fareva Amboise (Apr 10, 2026) FDA issued a warning letter to Fareva Amboise concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Data integrity and records, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Prida Import & Export LLC (Apr 10, 2026) FDA issued a warning letter to Prida Import & Export LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Accra Supermarket (Apr 10, 2026) FDA issued a warning letter to Accra Supermarket concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Full Fresh Produce LLC (Apr 10, 2026) FDA issued a warning letter to Full Fresh Produce LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Medical Products Laboratories, Inc. (Apr 9, 2026) FDA issued a warning letter to Medical Products Laboratories, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | Open |
Warning Letter vapepengood.com (Apr 9, 2026) FDA issued a warning letter to vapepengood.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter The Wilatta Group Inc. (Apr 8, 2026) FDA issued a warning letter to The Wilatta Group Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Chemco Corporation (Apr 7, 2026) FDA issued a warning letter to Chemco Corporation concerning Nonprescription/OTC. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Quality systems and CAPA, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Nonprescription/OTC | Open |
Warning Letter Nature’s Elements, Inc. (Apr 7, 2026) FDA issued a warning letter to Nature’s Elements, Inc. concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Dietary Supplement/Adulterated/Misbranded | Open |
Warning Letter ProRx LLC (Apr 7, 2026) FDA issued a warning letter to ProRx LLC concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Compounding Pharmacy/Adulterated Drug Products | Open |
Warning Letter Smart Vending Services, LLC (Apr 7, 2026) FDA issued a warning letter to Smart Vending Services, LLC concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Lexia LLC (Apr 7, 2026) FDA issued a warning letter to Lexia LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Labeling, claims, and misbranding, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter mohawksmoke.com (Apr 3, 2026) FDA issued a warning letter to mohawksmoke.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter The Fish Aid (Apr 3, 2026) FDA issued a warning letter to The Fish Aid concerning Unapproved New Animal Drug Products. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Animal Drug Products | Open |
Warning Letter Ridley USA Inc. (Apr 3, 2026) FDA issued a warning letter to Ridley USA Inc. concerning CGMP/Medicated Feeds/Adulterated. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Medicated Feeds/Adulterated | Open |
Warning Letter DK Hardware Supply (Apr 3, 2026) FDA issued a warning letter to DK Hardware Supply concerning Unapproved New Animal Drug Products. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Animal Drug Products | Open |
Warning Letter Purolea Cosmetics Lab (Apr 2, 2026) FDA issued a warning letter to Purolea Cosmetics Lab concerning CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | Open |
Warning Letter Beauty of Aztlan LLC (Apr 2, 2026) FDA issued a warning letter to Beauty of Aztlan LLC concerning Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet | Open |
Warning Letter Rxgoodusa (Apr 1, 2026) FDA issued a warning letter to Rxgoodusa concerning Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet | Open |
Warning Letter Online Rx Medz (Apr 1, 2026) FDA issued a warning letter to Online Rx Medz concerning Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet | Open |
Warning Letter Dry Springs Pharmacy (Apr 1, 2026) FDA issued a warning letter to Dry Springs Pharmacy concerning Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet | Open |
Warning Letter Pure Indulgence Aesthetics (Apr 1, 2026) FDA issued a warning letter to Pure Indulgence Aesthetics concerning Drug Supply Chain Security Act (DSCSA) Violations. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Drug Supply Chain Security Act (DSCSA) Violations | Open |
Warning Letter Zap Expo Center Inc. (Mar 31, 2026) FDA issued a warning letter to Zap Expo Center Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter PekCura Labs (Mar 31, 2026) FDA issued a warning letter to PekCura Labs concerning Unapproved New Drugs Sold Over the Internet. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs Sold Over the Internet | Open |
Warning Letter Gram Peptides (Mar 31, 2026) FDA issued a warning letter to Gram Peptides concerning Unapproved New Drugs Sold Over the Internet. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs Sold Over the Internet | Open |
Warning Letter Global Tobacco, LLC (Mar 31, 2026) FDA issued a warning letter to Global Tobacco, LLC concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter FormPour (Mar 31, 2026) FDA issued a warning letter to FormPour concerning Unapproved New Drugs Sold Over the Internet. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs Sold Over the Internet | Open |
Warning Letter Guangzhou Huli Technology Co., Ltd. dba Fantasy Face (Mar 31, 2026) FDA issued a warning letter to Guangzhou Huli Technology Co., Ltd. dba Fantasy Face concerning Unapproved New Drugs Sold Over the Internet. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs Sold Over the Internet | Open |
Warning Letter Lovega LLC dba Pink Pony Peptides (Mar 31, 2026) FDA issued a warning letter to Lovega LLC dba Pink Pony Peptides concerning Unapproved New Drugs Sold Over the Internet. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs Sold Over the Internet | Open |
Warning Letter Mile High Compounds LLC (Mar 31, 2026) FDA issued a warning letter to Mile High Compounds LLC concerning Unapproved New Drugs Sold Over the Internet. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs Sold Over the Internet | Open |
Warning Letter Prime Sciences (Mar 31, 2026) FDA issued a warning letter to Prime Sciences concerning Unapproved New Drugs Sold Over the Internet. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs Sold Over the Internet | Open |
Warning Letter DO&CO Aktiengesellschaft/DO&CO, Inc. (Mar 30, 2026) FDA issued a warning letter to DO&CO Aktiengesellschaft/DO&CO, Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Food safety and supplier verification, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | Open |
Warning Letter Intas Pharmaceuticals Limited (Mar 30, 2026) FDA issued a warning letter to Intas Pharmaceuticals Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Laboratory controls and testing, Quality systems and CAPA, Manufacturing and CGMP controls, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Ehsan Sadri, M.D. (Mar 27, 2026) FDA issued a warning letter to Ehsan Sadri, M.D. concerning Clinical Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Quality systems and CAPA, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Clinical Investigator | Open |
Warning Letter buydeltas.com (Mar 27, 2026) FDA issued a warning letter to buydeltas.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Baja Fresko Distributors Inc. (Mar 27, 2026) FDA issued a warning letter to Baja Fresko Distributors Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter J&B Food Consulting (Mar 27, 2026) FDA issued a warning letter to J&B Food Consulting concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Eaglelionton Int'l Trading Co Inc (Mar 26, 2026) FDA issued a warning letter to Eaglelionton Int'l Trading Co Inc concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Henan Lvyuan Pharmaceutical Co. Ltd. (Mar 26, 2026) FDA issued a warning letter to Henan Lvyuan Pharmaceutical Co. Ltd. concerning CGMP/API/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/API/Adulterated | Open |
Warning Letter Medline Industries, LP (Mar 25, 2026) FDA issued a warning letter to Medline Industries, LP concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Medical device quality and reporting, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/Adulterated | Open |
Warning Letter Xiamen Kang Zhongyuan Biotechnology Co., Ltd. (Mar 23, 2026) FDA issued a warning letter to Xiamen Kang Zhongyuan Biotechnology Co., Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Data integrity and records, Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Nupack Inc. (Mar 20, 2026) FDA issued a warning letter to Nupack Inc. concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Dietary Supplement/Adulterated/Misbranded | Open |
Warning Letter matesbrand.com (Mar 20, 2026) FDA issued a warning letter to matesbrand.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter RC Outsourcing, LLC (Mar 20, 2026) FDA issued a warning letter to RC Outsourcing, LLC concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Compounding Pharmacy/Adulterated Drug Products | Open |
Warning Letter Shang Hao Jia, Inc. (Mar 18, 2026) FDA issued a warning letter to Shang Hao Jia, Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Yangzhou H&R Plastic Daily Chemical Co., Ltd. (Mar 18, 2026) FDA issued a warning letter to Yangzhou H&R Plastic Daily Chemical Co., Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Schlechter Farms Inc. (Mar 18, 2026) FDA issued a warning letter to Schlechter Farms Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Open |
Warning Letter 4U Health (Mar 17, 2026) FDA issued a warning letter to 4U Health concerning Premarket Approval/Adulterated. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Premarket Approval/Adulterated | Closed |
Warning Letter Microbiological Testing & Consulting, LLC (Mar 16, 2026) FDA issued a warning letter to Microbiological Testing & Consulting, LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Data integrity and records, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter ImmunityBio, Inc. (Mar 13, 2026) FDA issued a warning letter to ImmunityBio, Inc. concerning False & Misleading Claims/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded | Open |
Warning Letter Patcos Cosmetics Pvt. Ltd. (Mar 12, 2026) FDA issued a warning letter to Patcos Cosmetics Pvt. Ltd. concerning Finished Drug Products/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Finished Drug Products/Adulterated | Open |
Warning Letter Adnan Dahdul, MD (Mar 12, 2026) FDA issued a warning letter to Adnan Dahdul, MD concerning Clinical Investigator/BIMO. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Quality systems and CAPA, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Clinical Investigator/BIMO | Open |
Warning Letter ISA Produce Corporation (Mar 12, 2026) FDA issued a warning letter to ISA Produce Corporation concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter OraLabs, Inc. (Mar 11, 2026) FDA issued a warning letter to OraLabs, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Flowchem Pharma Private Limited (Mar 11, 2026) FDA issued a warning letter to Flowchem Pharma Private Limited concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Open |
Warning Letter Vedic Lifesciences Pvt. Ltd. (Mar 9, 2026) FDA issued a warning letter to Vedic Lifesciences Pvt. Ltd. concerning Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. Deterministic full-text screening identifies discussion of Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | Open |
Warning Letter JZ Wholesale, Inc. (Mar 9, 2026) FDA issued a warning letter to JZ Wholesale, Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Open |
Warning Letter Middlefield Original Cheese Cooperative (Mar 6, 2026) FDA issued a warning letter to Middlefield Original Cheese Cooperative concerning CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | Open |
Warning Letter Espifresh Inc. (Mar 6, 2026) FDA issued a warning letter to Espifresh Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Half Hill Farm Inc. (Mar 6, 2026) FDA issued a warning letter to Half Hill Farm Inc. concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter prilla.com/us (Mar 6, 2026) FDA issued a warning letter to prilla.com/us concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Life Plus Style Gourmet LLC (Mar 5, 2026) FDA issued a warning letter to Life Plus Style Gourmet LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter SSS AUSTAR LLC (Mar 5, 2026) FDA issued a warning letter to SSS AUSTAR LLC concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Novo Nordisk Inc. (Mar 5, 2026) FDA issued a warning letter to Novo Nordisk Inc. concerning Postmarketing Adverse Drug Experience Reporting Requirements. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Postmarketing Adverse Drug Experience Reporting Requirements | Open |
Warning Letter Citra100mg (Mar 4, 2026) FDA issued a warning letter to Citra100mg concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Misbranded | Open |
Warning Letter Fareva Morton Grove (Mar 3, 2026) FDA issued a warning letter to Fareva Morton Grove concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Data integrity and records, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Ocean Group Inc. (Mar 3, 2026) FDA issued a warning letter to Ocean Group Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Quality systems and CAPA, Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Open |
Warning Letter Simtra BioPharma Solutions (Mar 3, 2026) FDA issued a warning letter to Simtra BioPharma Solutions concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Barcelona Nut Company Inc. (Mar 3, 2026) FDA issued a warning letter to Barcelona Nut Company Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Open |
Warning Letter Tentamus India Private Limited (Mar 3, 2026) FDA issued a warning letter to Tentamus India Private Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Data integrity and records, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter NSE Products, Inc. DBA Nu Skin Enterprises, Inc. (Mar 2, 2026) FDA issued a warning letter to NSE Products, Inc. DBA Nu Skin Enterprises, Inc. concerning Electronic Drug Registration and Listing System (eDRLS)/Violations. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Electronic Drug Registration and Listing System (eDRLS)/Violations | Closed |
Warning Letter thesnuslife.com (Feb 27, 2026) FDA issued a warning letter to thesnuslife.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter snushaven.com (Feb 27, 2026) FDA issued a warning letter to snushaven.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter idripejuice.com (Feb 27, 2026) FDA issued a warning letter to idripejuice.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Rio Verde Food Service Inc. (Feb 27, 2026) FDA issued a warning letter to Rio Verde Food Service Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Open |
Warning Letter Longhorn Vaccines and Diagnostics LLC (Feb 26, 2026) FDA issued a warning letter to Longhorn Vaccines and Diagnostics LLC concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Medical device quality and reporting, Quality systems and CAPA, Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/Adulterated | Open |
Warning Letter Trangs Group USA Incorporated (Feb 24, 2026) FDA issued a warning letter to Trangs Group USA Incorporated concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter IsoTis OrthoBiologics, Inc. (Feb 24, 2026) FDA issued a warning letter to IsoTis OrthoBiologics, Inc. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Medical device quality and reporting, Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/Adulterated | Open |
Warning Letter Genesis Health International Inc. dba Genesis (Feb 20, 2026) FDA issued a warning letter to Genesis Health International Inc. dba Genesis concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Peaks Curative, LLC dba Peaks (Feb 20, 2026) FDA issued a warning letter to Peaks Curative, LLC dba Peaks concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Join Josie (Feb 20, 2026) FDA issued a warning letter to Join Josie concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Kin Meds (Feb 20, 2026) FDA issued a warning letter to Kin Meds concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Premium Health Management Inc. dba Premium Health (Feb 20, 2026) FDA issued a warning letter to Premium Health Management Inc. dba Premium Health concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics (Feb 20, 2026) FDA issued a warning letter to Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Levity Inc. dba Levity (Feb 20, 2026) FDA issued a warning letter to Levity Inc. dba Levity concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Ivim Services LLC dba Ivim (Feb 20, 2026) FDA issued a warning letter to Ivim Services LLC dba Ivim concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter PharmaZee (Feb 20, 2026) FDA issued a warning letter to PharmaZee concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Weightless Medical LLC dba WeightCare (Feb 20, 2026) FDA issued a warning letter to Weightless Medical LLC dba WeightCare concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Newman Clinic, PLLC dba Newman Clinic (Feb 20, 2026) FDA issued a warning letter to Newman Clinic, PLLC dba Newman Clinic concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Lean Rx, Inc. dba SkinnyRx (Feb 20, 2026) FDA issued a warning letter to Lean Rx, Inc. dba SkinnyRx concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Better Health Labs, Inc. dba Measured (Feb 20, 2026) FDA issued a warning letter to Better Health Labs, Inc. dba Measured concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter MEDVi, LLC dba MEDVi (Feb 20, 2026) FDA issued a warning letter to MEDVi, LLC dba MEDVi concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Alan Health Technologies Inc. dba Alan (Feb 20, 2026) FDA issued a warning letter to Alan Health Technologies Inc. dba Alan concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Refills Health, LLC dba Refills Health (Feb 20, 2026) FDA issued a warning letter to Refills Health, LLC dba Refills Health concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter FitRX, LLC dba FitRx (Feb 20, 2026) FDA issued a warning letter to FitRX, LLC dba FitRx concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Zeuss LLC dba Zeuss (Feb 20, 2026) FDA issued a warning letter to Zeuss LLC dba Zeuss concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Strut Health, LLC dba Strut (Feb 20, 2026) FDA issued a warning letter to Strut Health, LLC dba Strut concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Kare Solutions, LLC dba Zappy (Feb 20, 2026) FDA issued a warning letter to Kare Solutions, LLC dba Zappy concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Viv Health, Inc. dba VIV RX (Feb 20, 2026) FDA issued a warning letter to Viv Health, Inc. dba VIV RX concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Good Girl LLC dba GoodGirlRX (Feb 20, 2026) FDA issued a warning letter to Good Girl LLC dba GoodGirlRX concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Bliv Wellness LLC dba Bliv (Feb 20, 2026) FDA issued a warning letter to Bliv Wellness LLC dba Bliv concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter NewSelf Limited dba NewSelf (Feb 20, 2026) FDA issued a warning letter to NewSelf Limited dba NewSelf concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter 24HrDoc, Inc. dba 24HrDoc (Feb 20, 2026) FDA issued a warning letter to 24HrDoc, Inc. dba 24HrDoc concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Belle Health LLC dba Belle (Feb 20, 2026) FDA issued a warning letter to Belle Health LLC dba Belle concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Dripgym Mobile Parent, LLC dba Amp Health (Feb 20, 2026) FDA issued a warning letter to Dripgym Mobile Parent, LLC dba Amp Health concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter BluefitMD (Feb 20, 2026) FDA issued a warning letter to BluefitMD concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter MaxLife Technologies Inc. dba Maxlife (Feb 20, 2026) FDA issued a warning letter to MaxLife Technologies Inc. dba Maxlife concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter Aspen Aesthetics dba Fifty 410 (Feb 20, 2026) FDA issued a warning letter to Aspen Aesthetics dba Fifty 410 concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded (Telehealth) | Open |
Warning Letter El Rey USA Meats & Seafood Inc. (Feb 19, 2026) FDA issued a warning letter to El Rey USA Meats & Seafood Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Open |
Warning Letter JMT Inter LLC (Feb 19, 2026) FDA issued a warning letter to JMT Inter LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Raw Bistro Inc. (Feb 17, 2026) FDA issued a warning letter to Raw Bistro Inc. concerning CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Laboratory controls and testing, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Open |
Warning Letter The Sabagh Group Inc/lighterusa.com (Feb 13, 2026) FDA issued a warning letter to The Sabagh Group Inc/lighterusa.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter swedishproducts.online (Feb 13, 2026) FDA issued a warning letter to swedishproducts.online concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter AQ USA Inc., d.b.a Ross Healthcare Inc. (Feb 12, 2026) FDA issued a warning letter to AQ USA Inc., d.b.a Ross Healthcare Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Black Sheep Egg Company, LLC (Feb 12, 2026) FDA issued a warning letter to Black Sheep Egg Company, LLC concerning PHS Act/Shell Egg Regulation/Adulterated. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA PHS Act/Shell Egg Regulation/Adulterated | Open |
Warning Letter A. Nelson & Co. Ltd. (Feb 12, 2026) FDA issued a warning letter to A. Nelson & Co. Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Dynamic Stem Cell Therapy (Feb 11, 2026) FDA issued a warning letter to Dynamic Stem Cell Therapy concerning Unapproved New Drugs/Unlicensed Biological Product Violations. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs/Unlicensed Biological Product Violations | Open |
Warning Letter ProDx Health (Feb 10, 2026) FDA issued a warning letter to ProDx Health concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | Open |
Warning Letter Hearthy Foods, Inc. (Feb 10, 2026) FDA issued a warning letter to Hearthy Foods, Inc. concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Dietary Supplement/Adulterated/Misbranded | Open |
Warning Letter A TO Z Distributor Inc (Feb 10, 2026) FDA issued a warning letter to A TO Z Distributor Inc concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter VeganicSKN Limited (Feb 9, 2026) FDA issued a warning letter to VeganicSKN Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Thrive Health and Wellness, LLC dba Thrive Health Solutions (Feb 9, 2026) FDA issued a warning letter to Thrive Health and Wellness, LLC dba Thrive Health Solutions concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Compounding Pharmacy/Adulterated Drug Products | Closed |
Warning Letter Cosmetic Manufacturers Pty Ltd. (Feb 6, 2026) FDA issued a warning letter to Cosmetic Manufacturers Pty Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter ExThera Medical Corporation (Feb 6, 2026) FDA issued a warning letter to ExThera Medical Corporation concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Labeling, claims, and misbranding, Unapproved products and premarket authorization, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | Open |
Warning Letter Bio-Medical Pharmaceutical Manufacturing Corporation (Feb 5, 2026) FDA issued a warning letter to Bio-Medical Pharmaceutical Manufacturing Corporation concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Labeling, claims, and misbranding, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Beach Weekend Management LLC dba Nic and Jet Fuel (Feb 5, 2026) FDA issued a warning letter to Beach Weekend Management LLC dba Nic and Jet Fuel concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Unapproved New Drugs | Open |
Warning Letter Mark S. Dacey, M.D. (Feb 2, 2026) FDA issued a warning letter to Mark S. Dacey, M.D. concerning Clinical Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Data integrity and records, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Clinical Investigator | Open |
Warning Letter Stream2Sea, LLC (Feb 2, 2026) FDA issued a warning letter to Stream2Sea, LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Data integrity and records, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Apollo Care, LLC (Feb 2, 2026) FDA issued a warning letter to Apollo Care, LLC concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Compounding Pharmacy/Adulterated Drug Products | Open |
Warning Letter Bertrand P. Cole, D.O. (Feb 2, 2026) FDA issued a warning letter to Bertrand P. Cole, D.O. concerning Clinical Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Clinical Investigator | Open |
Warning Letter gotpouches.com (Jan 30, 2026) FDA issued a warning letter to gotpouches.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Cohance Lifesciences Limited (Jan 30, 2026) FDA issued a warning letter to Cohance Lifesciences Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter niqpouches.com (Jan 30, 2026) FDA issued a warning letter to niqpouches.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter Central Coast Multispecialty Medical Group, Inc. (Jan 29, 2026) FDA issued a warning letter to Central Coast Multispecialty Medical Group, Inc. concerning Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | Open |
Warning Letter Fidelity Melon, Inc (Jan 29, 2026) FDA issued a warning letter to Fidelity Melon, Inc concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Diasol, Inc. (Jan 29, 2026) FDA issued a warning letter to Diasol, Inc. concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | Open |
Warning Letter Beta Bionics, Inc. (Jan 28, 2026) FDA issued a warning letter to Beta Bionics, Inc. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/Adulterated | Open |
Warning Letter Flextronics America LLC (Jan 27, 2026) FDA issued a warning letter to Flextronics America LLC concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Medical device quality and reporting, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/Adulterated | Open |
Warning Letter Conceive Fertility Center (Jan 27, 2026) FDA issued a warning letter to Conceive Fertility Center concerning Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps). Deterministic full-text screening identifies discussion of Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | Open |
Warning Letter HTO Nevada, Inc. dba Kirkman (Jan 27, 2026) FDA issued a warning letter to HTO Nevada, Inc. dba Kirkman concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Abbott Diabetes Care, Inc. (Jan 23, 2026) FDA issued a warning letter to Abbott Diabetes Care, Inc. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Laboratory controls and testing, Quality systems and CAPA, Medical device quality and reporting, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/Adulterated | Open |
Warning Letter Intelligent Remedies, Inc. (Jan 23, 2026) FDA issued a warning letter to Intelligent Remedies, Inc. concerning New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA New Drug/Misbranded | Open |
Warning Letter Louisville Reproductive Center (Jan 23, 2026) FDA issued a warning letter to Louisville Reproductive Center concerning Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps). No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | Open |
Warning Letter Tombak LLC (Jan 22, 2026) FDA issued a warning letter to Tombak LLC concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Open |
Warning Letter South Bay Cold Storage & Handling, Inc. (Jan 22, 2026) FDA issued a warning letter to South Bay Cold Storage & Handling, Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Open |
Warning Letter Diamond-Herpanacine of PA, Inc. (Jan 22, 2026) FDA issued a warning letter to Diamond-Herpanacine of PA, Inc. concerning New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA New Drug/Misbranded | Open |
Warning Letter Supersmart USA, LLC (Jan 21, 2026) FDA issued a warning letter to Supersmart USA, LLC concerning New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA New Drug/Misbranded | Open |
Warning Letter Signature Formulations, LLC (Jan 21, 2026) FDA issued a warning letter to Signature Formulations, LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Naumes, Inc. (Jan 21, 2026) FDA issued a warning letter to Naumes, Inc. concerning Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated | Open |
Warning Letter GenoGenix LLC (Jan 20, 2026) FDA issued a warning letter to GenoGenix LLC concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Compounding Pharmacy/Adulterated Drug Products | Open |
Warning Letter East CK Trading Inc. (Jan 16, 2026) FDA issued a warning letter to East CK Trading Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Zip Foods Importers, Inc (Jan 16, 2026) FDA issued a warning letter to Zip Foods Importers, Inc concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Open |
Warning Letter Feng Foods Trading Inc. (Jan 16, 2026) FDA issued a warning letter to Feng Foods Trading Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Open |
Warning Letter Boothwyn Pharmacy, LLC (Jan 16, 2026) FDA issued a warning letter to Boothwyn Pharmacy, LLC concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Laboratory controls and testing, Labeling, claims, and misbranding, Quality systems and CAPA, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Compounding Pharmacy/Adulterated Drug Products | Open |
Warning Letter The Great Smart African Food LLC (Jan 15, 2026) FDA issued a warning letter to The Great Smart African Food LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Foreign Supplier Verification Program (FSVP) | Closed |
Warning Letter Fulijaya Manufacturing SDN. BHD. (Jan 14, 2026) FDA issued a warning letter to Fulijaya Manufacturing SDN. BHD. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Data integrity and records, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
Warning Letter Min Jiang Food Store Inc dba Koi Koi Trading (Jan 14, 2026) FDA issued a warning letter to Min Jiang Food Store Inc dba Koi Koi Trading concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Open |
Warning Letter Center For Immunology Science, LLC (Jan 13, 2026) FDA issued a warning letter to Center For Immunology Science, LLC concerning Sponsor/Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Unapproved products and premarket authorization, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Sponsor/Investigator | Open |
Warning Letter CC Pollen Company (Jan 9, 2026) FDA issued a warning letter to CC Pollen Company concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Dietary Supplement/Adulterated/Misbranded | Open |
Warning Letter Germaphobix (Jan 9, 2026) FDA issued a warning letter to Germaphobix concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | Closed |
Warning Letter Christopher Dale Butler (Jan 9, 2026) FDA issued a warning letter to Christopher Dale Butler concerning Acidified Foods/Emergency Permit Control/Adulterated. Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Acidified Foods/Emergency Permit Control/Adulterated | Open |
Warning Letter Prodrome Sciences USA, LLC (Jan 8, 2026) FDA issued a warning letter to Prodrome Sciences USA, LLC concerning Sponsor/Unapproved Misbranded. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Quality systems and CAPA, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Sponsor/Unapproved Misbranded | Open |
Warning Letter Genovate (Jan 8, 2026) FDA issued a warning letter to Genovate concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | Open |
Warning Letter Unomedical Device S.A. de C.V. (Jan 8, 2026) FDA issued a warning letter to Unomedical Device S.A. de C.V. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/QSR/Medical Devices/Adulterated | Open |
Warning Letter Elanco Animal Health USA (Jan 8, 2026) FDA issued a warning letter to Elanco Animal Health USA concerning False & Misleading Claims/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA False & Misleading Claims/Misbranded | Closed |
Warning Letter Genetrace (Jan 8, 2026) FDA issued a warning letter to Genetrace concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | Open |
Warning Letter Winder Laboratories, LLC (Jan 7, 2026) FDA issued a warning letter to Winder Laboratories, LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout. | WL | Issued | US FDA CGMP/Finished Pharmaceuticals/Adulterated | Open |
