FDA warning letters: Drug manufacturing (CGMP)

This page lists public FDA records related to Drug manufacturing (CGMP). Inclusion does not mean a company is currently out of compliance. Topics are assigned by keyword matching on FDA's subject line.

63 letters in the current window. Last checked Oct 16, 2026.

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CompanyLetter dateFDA subject
Eurofins SF Analytical Laboratories, Inc.Oct 6, 2026CGMP/Finished Pharmaceuticals/Adulterated
Hanlim Pharm Co., Ltd.Oct 2, 2026CGMP/Finished Pharmaceuticals/Adulterated
Dreyer’s Grand Ice Cream, Inc.Sep 29, 2026CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Jiangmen Shuizirun Sanitary Articles Co., Ltd.Sep 23, 2026CGMP/Finished Pharmaceuticals/Adulterated
Sciarra Aeromed, Inc.Sep 23, 2026CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Neogen CorporationSep 23, 2026CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Unilam Co., LTDSep 22, 2026CGMP/QSR/Medical Devices/Adulterated
Fresenius Kabi USA LLCSep 22, 2026CGMP/Finished Pharmaceuticals/Adulterated
Babikian Healthcare Products CJSCSep 21, 2026CGMP/Finished Pharmaceuticals/Adulterated
Curia New York, Inc.Sep 18, 2026CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Empower Clinic Services, LLC dba Empower PharmacySep 18, 2026CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Bentley Laboratories LLCSep 17, 2026CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
SCA Pharmaceuticals, LLCSep 14, 2026CGMP/Finished Pharmaceuticals/Adulterated
Ocean Pride Seafood, Inc.Sep 11, 2026Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
RDM Express Inc.Sep 11, 2026CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
kdc/one Chatsworth, Inc.Sep 8, 2026CGMP/Finished Pharmaceuticals/Adulterated
TCI Co., Ltd BioCosme PABP BRANCHSep 2, 2026CGMP/Finished Pharmaceuticals/Adulterated
Star Ocean Wholesale Foods, Inc.Sep 1, 2026Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Happy Farm Botanicals, Inc.Sep 1, 2026CGMP/Finished Pharmaceuticals/Adulterated
Tipical Latin Food, Corp. DBA La PraderaAug 28, 2026CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Jabil Inc.Aug 27, 2026CGMP/Finished Pharmaceuticals/Adulterated
Fresenius Medical Care AG & Co. KGaAAug 25, 2026CGMP/Finished Pharmaceuticals/Adulterated
South Asian Food Inc.Aug 20, 2026Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Reliance Life Sciences Private LimitedAug 18, 2026CGMP/Finished Pharmaceuticals/Adulterated
Shoolin Pharma Chem LLPAug 18, 2026CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
PReye, LLCAug 18, 2026CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Suretec Innovations, LLCAug 13, 2026CGMP/Finished Pharmaceuticals/Adulterated and Misbranded
Eugia Pharma Specialities LimitedAug 13, 2026CGMP/Finished Pharmaceuticals/Adulterated
K.C. Pharmaceuticals, Inc.Aug 12, 2026CGMP/Finished Pharmaceuticals/Adulterated
Auriga Research Pvt. Ltd.Aug 12, 2026CGMP/Finished Pharmaceuticals/Adulterated
Safrel Pharmaceuticals LLCAug 7, 2026CGMP/Finished Pharmaceuticals/Adulterated
Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.Aug 6, 2026CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
Lewis Sausage Company Inc.Aug 5, 2026CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
American Pharma Mfg. Inc.Aug 4, 2026CGMP/Dietary Supplement/Adulterated/Misbranded
FairyGene, Inc.Jul 31, 2026CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Lico Industries, LLC., d.b.a. American Towelette CompanyJul 30, 2026CGMP/Finished Pharmaceuticals/Adulterated
Woodbine Products Company Inc.Jul 27, 2026CGMP/Finished Pharmaceuticals/Adulterated
Nipro Renal Solutions USA, CorporationJul 24, 2026CGMP/QSR/Medical Devices/Adulterated
Dabur India LimitedJul 24, 2026CGMP/Finished Pharmaceuticals/Adulterated
Thomas Brunner Hygiene GmbHJul 24, 2026CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
ABS CorporationJul 23, 2026CGMP/Finished Pharmaceuticals/Adulterated
Koven Technologies, Inc.Jul 21, 2026CGMP/QSR/Medical Devices/Adulterated
Island Kinetics, Inc. d.b.a. CoValence LaboratoriesJul 16, 2026CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
BioMylz Pvt. Ltd.Jul 13, 2026CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Almon Healthcare Private LimitedJul 13, 2026CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Spa De Soleil, Inc.Jul 8, 2026CGMP/Finished Pharmaceuticals/Adulterated
Specialty Health Products CO, LLCJul 7, 2026CGMP/QSR/Medical Devices/Adulterated
Waves and Wine, Inc.Jul 6, 2026CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated
International Medication Systems LimitedJul 2, 2026CGMP/Finished Pharmaceuticals/Adulterated
Wizcure Pharmaa Private LimitedJun 24, 2026CGMP/Finished Pharmaceuticals/Adulterated
Genzyme Ireland LimitedJun 22, 2026CGMP/Deviations/Biologics License Application (BLA)
Huons Co., Ltd.Jun 15, 2026CGMP/Finished Pharmaceuticals/Adulterated
AHC Products, Inc.Jun 12, 2026CGMP/Finished Pharmaceuticals/Adulterated
Nutratech, LLCJun 4, 2026CGMP/Dietary Supplement/Adulterated/Misbranded
Linemaster Switch CorporationMay 27, 2026CGMP/QSR/Drug/Medical Devices/Adulterated
AF Import & Wholesale CoMay 26, 2026Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
ZIIP, Inc.May 22, 2026CGMP/QSR/Medical Devices/Adulterated
3B Medical, Inc. dba Reach Health, Inc.May 20, 2026CGMP/QSR/Medical Devices/Adulterated
BMC Medical Co., Ltd.May 20, 2026CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
Wellmill, LLC dba Vitamix LaboratoriesApr 20, 2026Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
VeganicSKN LimitedFeb 9, 2026CGMP/Finished Pharmaceuticals/Adulterated
Stream2Sea, LLCFeb 2, 2026CGMP/Finished Pharmaceuticals/Adulterated
Kellin Chemicals Co., Ltd. - ZhangjiagangNov 6, 2025CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

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