CFSAN FDA Letters

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.

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.

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.

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.

FDA issued a warning letter to Nutratech, LLC 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 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.

FDA issued a warning letter to Meta Labs Pharmaceuticals, LLC concerning Dietary Supplement/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 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.

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.

FDA issued a warning letter to Dough-To-Go, Inc. concerning CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated. Deterministic source-metadata 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.

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.

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 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 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 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 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.

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.

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.

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.

FDA issued a warning letter to Half Hill Farm Inc. concerning Unapproved New Drugs/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 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.

FDA issued a warning letter to Barcelona Nut Company 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 Rio Verde Food Service Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic source-metadata 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.

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.

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.

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.

FDA issued a warning letter to South Bay Cold Storage & Handling, Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic source-metadata 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.

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.

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.

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.

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.

FDA issued a warning letter to CC Pollen Company 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 Christopher Dale Butler concerning Acidified Foods/Emergency Permit Control/Adulterated. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.