enforcement database
FDA cGMP Warning Letters
96 documented actions on record. Warning letters citing current Good Manufacturing Practice violations.
- Total actions
- 96
- Earliest on record
- February 2, 2026
- Most recent
- September 23, 2026
- Source
- openFDA (warning_letter)
Severity breakdown
- Critical55
- High41
Most recent cgmp warning letters (30 of 96 shown)
- Neogen Corporation — CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated (2026-09-23)
September 23, 2026·High
- Sciarra Aeromed, Inc. — CGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated (2026-09-23)
September 23, 2026·High
- Unilam Co., LTD — CGMP/QSR/Medical Devices/Adulterated (2026-09-22)
September 22, 2026·High
- Fresenius Kabi AG — CGMP/Finished Pharmaceuticals/Adulterated (2026-09-22)
September 22, 2026·Critical
- Babikian Healthcare Products CJSC — CGMP/Finished Pharmaceuticals/Adulterated (2026-09-21)
September 21, 2026·High
- Empower Clinic Services, LLC dba Empower Pharmacy — CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug (2026-09-18)
September 18, 2026·Critical
- Curia New York, Inc. — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (2026-09-18)
September 18, 2026·Critical
- Bentley Laboratories LLC — CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated (2026-09-17)
September 17, 2026·Critical
- kdc/one Chatsworth, Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-09-08)
September 8, 2026·Critical
- Bausch & Lomb Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-09-04)
September 4, 2026·Critical
- TCI Co., Ltd BioCosme PABP BRANCH — CGMP/Finished Pharmaceuticals/Adulterated (2026-09-02)
September 2, 2026·High
- Happy Farm Botanicals, Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-09-01)
September 1, 2026·Critical
- Tipical Latin Food, Corp. DBA La Pradera — CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions (2026-08-28)
August 28, 2026·High
- Jabil Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-27)
August 27, 2026·Critical
- Fresenius Medical Care AG & Co. KGaA — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-25)
August 25, 2026·Critical
- Shoolin Pharma Chem LLP — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (2026-08-18)
August 18, 2026·High
- Reliance Life Sciences Private Limited — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-18)
August 18, 2026·Critical
- PReye, LLC — CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug (2026-08-18)
August 18, 2026·Critical
- Binh Minh Tofu — CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated (2026-08-18)
August 18, 2026·High
- Eugia Pharma Specialities Limited — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-13)
August 13, 2026·Critical
- Suretec Innovations, LLC — CGMP/Finished Pharmaceuticals/Adulterated and Misbranded (2026-08-13)
August 13, 2026·High
- K.C. Pharmaceuticals, Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-12)
August 12, 2026·Critical
- Auriga Research Pvt. Ltd. — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-12)
August 12, 2026·Critical
- Safrel Pharmaceuticals LLC — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-07)
August 7, 2026·Critical
- Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded (2026-08-06)
August 6, 2026·High
- American Pharma Mfg. Inc. — CGMP/Dietary Supplement/Adulterated/Misbranded (2026-08-04)
August 4, 2026·Critical
- Woodbine Products Company Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-07-27)
July 27, 2026·High
- Thomas Brunner Hygiene GmbH — CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated (2026-07-24)
July 24, 2026·Critical
- Nipro Renal Solutions USA, Corporation — CGMP/QSR/Medical Devices/Adulterated (2026-07-24)
July 24, 2026·High
- Dabur India Limited — CGMP/Finished Pharmaceuticals/Adulterated (2026-07-24)
July 24, 2026·Critical
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.