enforcement database
FDA cGMP Warning Letters
78 documented actions on record. Warning letters citing current Good Manufacturing Practice violations.
- Total actions
- 78
- Earliest on record
- April 7, 2026
- Most recent
- August 27, 2026
- Source
- openFDA (warning_letter)
Severity breakdown
- Critical45
- High33
Most recent cgmp warning letters (30 of 78 shown)
- 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
- PReye, LLC — CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug (2026-08-18)
August 18, 2026·Critical
- Reliance Life Sciences Private Limited — CGMP/Finished Pharmaceuticals/Adulterated (2026-08-18)
August 18, 2026·Critical
- 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
- 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
- Dabur India Limited — CGMP/Finished Pharmaceuticals/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
- ABS Corporation — CGMP/Finished Pharmaceuticals/Adulterated (2026-07-23)
July 23, 2026·High
- Koven Technologies, Inc. — CGMP/QSR/Medical Devices/Adulterated (2026-07-21)
July 21, 2026·Critical
- Island Kinetics, Inc. d.b.a. CoValence Laboratories — CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated (2026-07-16)
July 16, 2026·Critical
- Almon Healthcare Private Limited — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (2026-07-13)
July 13, 2026·High
- Shimoga Chemicals — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (2026-07-13)
July 13, 2026·Critical
- BioMylz Pvt. Ltd. — CGMP/Finished Pharmaceuticals/Adulterated/Misbranded (2026-07-13)
July 13, 2026·Critical
- Spa De Soleil, Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-07-08)
July 8, 2026·High
- Waves and Wine, Inc. — CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated (2026-07-06)
July 6, 2026·High
- International Medication Systems Limited — CGMP/Finished Pharmaceuticals/Adulterated (2026-07-02)
July 2, 2026·Critical
- Excelvision - Fareva — CGMP/Finished Pharmaceuticals/Adulterated (2026-06-25)
June 25, 2026·Critical
- Wizcure Pharmaa Private Limited — CGMP/Finished Pharmaceuticals/Adulterated (2026-06-24)
June 24, 2026·Critical
- Genzyme Ireland Limited — CGMP/Deviations/Biologics License Application (BLA) (2026-06-22)
June 22, 2026·Critical
- Huons Co., Ltd. — CGMP/Finished Pharmaceuticals/Adulterated (2026-06-15)
June 15, 2026·Critical
- AHC Products, Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-06-12)
June 12, 2026·High
- Sante Manufacturing Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-06-05)
June 5, 2026·High
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.