FDA Letters Issued in April 2026

FDA issued an approval letter for EPYSQLI on 2026-04-30. The source metadata identifies BLA 761340 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PAVBLU on 2026-04-30. The source metadata identifies BLA 761298 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to CareFusion 213, LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic source-metadata 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.

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.

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.

FDA issued a warning letter to OptiHealth Products, Inc. concerning New Drug/Misbranded. Deterministic source-metadata 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.

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.

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.

FDA issued a warning letter to Sahara Enterprise Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic source-metadata 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.

FDA issued a warning letter to Shineluck Foods, Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes. Deterministic source-metadata 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.

FDA issued an approval letter for ZITUVIMET on 2026-04-28. The source metadata identifies NDA 216743 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CRYSVITA on 2026-04-27. The source metadata identifies BLA 761068 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PERJETA on 2026-04-27. The source metadata identifies BLA 125409 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VOQUEZNA TRIPLE PAK on 2026-04-27. The source metadata identifies NDA 215152 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA QLEX on 2026-04-27. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CLARITIN on 2026-04-27. The source metadata identifies NDA 021952 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ADDERALL XR 10, ADDERALL XR 20, ADDERALL XR 30 on 2026-04-27. The source metadata identifies NDA 021303, NDA 021977, NDA 022063, NDA 208510 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for METRO I.V. IN PLASTIC CONTAINER on 2026-04-27. The source metadata identifies NDA 018900 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SAPHNELO on 2026-04-27. The source metadata identifies BLA 761451 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CAPLYTA on 2026-04-27. The source metadata identifies NDA 209500 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CHILDREN'S CLARITIN, CLARITIN on 2026-04-27. The source metadata identifies NDA 021891 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DUPIXENT on 2026-04-24. The source metadata identifies BLA 761055 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IC-GREEN on 2026-04-24. The source metadata identifies NDA 011525 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

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.

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.

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.

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.

FDA issued a warning letter to Great One Trading Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic source-metadata 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.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued a warning letter to Global Imports Origins concerning Foreign Supplier Verification Program (FSVP). Deterministic source-metadata 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.

FDA issued a warning letter to jadepouch.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata 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.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued a warning letter to Minh Phung, Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Deterministic source-metadata 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.

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.

FDA issued a warning letter to Estar Technologies Ltd concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Deterministic source-metadata screening identifies discussion of 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.

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.

FDA issued an approval letter for SPRAVATO on 2026-04-21. The source metadata identifies NDA 211243 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IDVYNSO on 2026-04-21. The source metadata identifies NDA 216964 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZURZUVAE on 2026-04-21. The source metadata identifies NDA 217369 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TZIELD on 2026-04-21. The source metadata identifies BLA 761183 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Daily Manufacturing Solutions Inc. concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata 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.

FDA issued an approval letter for DANZITEN on 2026-04-20. The source metadata identifies NDA 219293 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ABREVA on 2026-04-20. The source metadata identifies NDA 020941 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for COSENTYX on 2026-04-20. The source metadata identifies BLA 125504, BLA 761349 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for COSENTYX on 2026-04-20. The source metadata identifies BLA 761349, BLA 125504 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZARXIO on 2026-04-20. The source metadata identifies BLA 125553 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DUPIXENT on 2026-04-20. The source metadata identifies BLA 761055 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

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.

FDA issued a warning letter to Respilon Production S.R.O. concerning CGMP/OTC/Finished Pharmaceuticals/Adulterated. Deterministic source-metadata 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.

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.

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.

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.

FDA issued an approval letter for DIACOMIT on 2026-04-16. The source metadata identifies NDA 206709, NDA 207223 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DATSCAN on 2026-04-16. The source metadata identifies NDA 022454 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for WAINUA (AUTOINJECTOR), WAINUA on 2026-04-16. The source metadata identifies NDA 217388 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for STELARA on 2026-04-16. The source metadata identifies BLA 761044, BLA 125261 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ITOVEBI on 2026-04-16. The source metadata identifies NDA 219249 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARTESUNATE on 2026-04-15. The source metadata identifies NDA 213036 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VANFLYTA on 2026-04-15. The source metadata identifies NDA 216993 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for AVLAYAH on 2026-04-15. The source metadata identifies BLA 761485 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RYTELO on 2026-04-15. The source metadata identifies NDA 217779 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FILSPARI on 2026-04-15. The source metadata identifies NDA 216403 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

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.

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.

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.

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.

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.

FDA issued an approval letter for TOBRADEX on 2026-04-14. The source metadata identifies NDA 050592 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Pro Numb Tattoo Numbing Spray, LLC concerning Nonprescription/OTC. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.

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.

FDA issued a warning letter to Ava Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic source-metadata 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.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued an approval letter for CONCERTA on 2026-04-13. The source metadata identifies NDA 021121 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to UCSF Radiopharmaceutical Facility concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic source-metadata 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.

FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Statistical analysis, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued an approval letter for COSOPT PF on 2026-04-10. The source metadata identifies NDA 202667 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VABYSMO on 2026-04-10. The source metadata identifies BLA 761235 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ONUREG on 2026-04-10. The source metadata identifies NDA 214120 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for REZENOPY on 2026-04-10. The source metadata identifies NDA 215487 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

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.

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.

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.

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.

FDA issued an approval letter for CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER on 2026-04-09. The source metadata identifies NDA 050821 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRIKAFTA (COPACKAGED) on 2026-04-09. The source metadata identifies NDA 212273, NDA 217660 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PLUVICTO on 2026-04-09. The source metadata identifies NDA 215833 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SKYCLARYS on 2026-04-09. The source metadata identifies NDA 216718 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BEYFORTUS on 2026-04-09. The source metadata identifies BLA 761328 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for INGREZZA SPRINKLE on 2026-04-09. The source metadata identifies NDA 218390 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

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.

FDA issued a warning letter to vapepengood.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata 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.

FDA issued a warning letter to The Wilatta Group Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic source-metadata 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.

FDA issued an approval letter for MAVYRET on 2026-04-07. The source metadata identifies NDA 209394 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ABLYSINOL on 2026-04-07. The source metadata identifies NDA 207987 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RETIN-A MICRO, RETIN-A-MICRO on 2026-04-07. The source metadata identifies NDA 020475 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TYVASO on 2026-04-07. The source metadata identifies NDA 022387 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZYNRELEF KIT on 2026-04-07. The source metadata identifies NDA 211988 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA on 2026-04-07. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA QLEX on 2026-04-07. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

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.

FDA issued a warning letter to Nature’s Elements, Inc. concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic source-metadata 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.

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.

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.

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.

FDA issued an approval letter for EYLEA HD on 2026-04-06. The source metadata identifies BLA 761355 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NINTEDANIB ESYLATE on 2026-04-06. The source metadata identifies ANDA 219227 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to mohawksmoke.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata 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.

FDA issued a warning letter to The Fish Aid concerning Unapproved New Animal Drug Products. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.

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.

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.

FDA issued an approval letter for STAVZOR on 2026-04-02. The source metadata identifies NDA 022152 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for INBRIJA on 2026-04-02. The source metadata identifies NDA 209184 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FOUNDAYO on 2026-04-02. The source metadata identifies NDA 220934 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARZERRA, KESIMPTA on 2026-04-02. The source metadata identifies BLA 125326 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VAFSEO on 2026-04-02. The source metadata identifies NDA 215192 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DEPAKOTE, DEPAKOTE ER on 2026-04-02. The source metadata identifies NDA 018723, NDA 019680, NDA 021168 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

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.

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.

FDA issued an approval letter for VIGAFYDE on 2026-04-01. The source metadata identifies NDA 217684 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Rxgoodusa concerning Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.

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.

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.

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.