enforcement database
FDA cGMP Warning Letters
59 documented actions on record. Warning letters citing current Good Manufacturing Practice violations.
- Total actions
- 59
- Earliest on record
- April 7, 2026
- Most recent
- July 16, 2026
- Source
- openFDA (warning_letter)
Severity breakdown
- Critical34
- High25
Most recent cgmp warning letters (30 of 59 shown)
- Island Kinetics, Inc. d.b.a. CoValence Laboratories — CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated (2026-07-16)
July 16, 2026·Critical
- BioMylz Pvt. Ltd. — CGMP/Finished Pharmaceuticals/Adulterated/Misbranded (2026-07-13)
July 13, 2026·Critical
- Shimoga Chemicals — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (2026-07-13)
July 13, 2026·Critical
- Almon Healthcare Private Limited — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (2026-07-13)
July 13, 2026·High
- Spa De Soleil, Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-07-08)
July 8, 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
- Sante Manufacturing Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-06-05)
June 5, 2026·High
- Nutratech, LLC — CGMP/Dietary Supplement/Adulterated/Misbranded (2026-06-04)
June 4, 2026·High
- Hubei Gedian Humanwell Pharmaceutical Co., Ltd. — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (2026-06-03)
June 3, 2026·High
- Gopaldas Visram & Co., Ltd. — CGMP/OTC Finished Pharmaceuticals/Adulterated (2026-06-02)
June 2, 2026·Critical
- PLZ Corp — CGMP/OTC Finished Pharmaceuticals/Adulterated (2026-06-02)
June 2, 2026·High
- Umendra Life Sciences Private Limited — CGMP/OTC Finished Pharmaceuticals/Adulterated (2026-06-02)
June 2, 2026·High
- Asanuma Corporation - Sagamihara Factory — CGMP/OTC Finished Pharmaceuticals/Adulterated (2026-06-02)
June 2, 2026·High
- Erkul Kozmetik Sanayi ve Ticaret A.S. — CGMP/OTC Finished Pharmaceuticals/Adulterated (2026-06-02)
June 2, 2026·High
- Revlon Group Holdings, LLC — CGMP/OTC Finished Pharmaceuticals/Adulterated (2026-06-02)
June 2, 2026·Critical
- Shantou Qiwei Industry Co., LTD — CGMP/OTC Finished Pharmaceuticals/Adulterated (2026-06-02)
June 2, 2026·High
- Laboratorios Dr. Collado S.A. — CGMP/OTC Finished Pharmaceuticals/Adulterated (2026-06-02)
June 2, 2026·High
- Zydus Lifesciences Limited — Request for Records/CGMP/Finished Pharmaceuticals/Adulterated (2026-06-02)
June 2, 2026·Critical
- Jubilant HollisterStier General Partnership — CGMP/Finished Pharmaceuticals/Adulterated (2026-05-28)
May 28, 2026·Critical
- Medline Inc — CGMP/Finished Pharmaceuticals/Adulterated (2026-05-28)
May 28, 2026·Critical
- Pharmathen International S.A. — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (2026-05-27)
May 27, 2026·Critical
- Linemaster Switch Corporation — CGMP/QSR/Drug/Medical Devices/Adulterated (2026-05-27)
May 27, 2026·Critical
- AF Import & Wholesale Co — Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions (2026-05-26)
May 26, 2026·High
- Laboratorios Jaloma S.A. de C.V. — CGMP/OTC/Finished Pharmaceuticals/Adulterated (2026-05-22)
May 22, 2026·Critical
- ZIIP, Inc. — CGMP/QSR/Medical Devices/Adulterated (2026-05-22)
May 22, 2026·High
- Alchymars ICM SM Private Limited — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (2026-05-21)
May 21, 2026·High
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.