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EXPLORE AND TRACK RECENT WARNING LETTERS AND INSPECTION ALERTS
Explore selected warning letters and inspection alerts in one central place — clearly organized, easy to search, and always up to date. Request a demo and never miss any compliance news again.
WARNING LETTERS AND INSPECTION ALERTS 2026
NELSONS (LONDON) received a warning letter on 2026-02-12 based on an inspection on 2025-09-19.
In the last five years, NELSONS received no other warning letters from the FDA.
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AQ USA, INC. (WASHINGTON) received a warning letter on 2026-02-12 based on an inspection on 2025-08-12.
In the last five years, AQ USA, INC. received no other warning letters from the FDA.
BIO MEDICAL & PHARM MANUFACTURING CORPORATION (HOUSTON) received a warning letter on 2026-02-05 based on an inspection on 2025-08-29.
In the last five years, BIO-MEDICAL PHARMACEUTICAL MANUFACTURING CORP. received no other warning letters from the FDA.
PANACEA BIOTEC PHARMA LTD (SOLAN) was inspected on 2026-01-31 by EDQM and found GMP non-compliant.
The previous USFDA inspection occured on 2023-10-12, and the site was found to be non-compliant at that time.
COHANCE LIFESCIENCES LTD. (NACHARAM – FDF UNIT I) received a warning letter on 2026-01-30 based on an inspection on 2025-08-12.
In the last five years, COHANCE LIFESCIENCES LTD received no other warning letters from the FDA.
KIRKMAN GROUP (LAKE OSWEGO) received a warning letter on 2026-01-27 based on an inspection on 2025-08-22.
In the last five years, KIRKMAN GROUP received no other warning letters from the FDA. One more warning letter was issued more than 5 years ago and has not been closed yet.
ABBOTT DIABETES CARE INC. (ALAMEDA) received a warning letter on 2026-01-23 based on an inspection on 2025-10-23.
In the last five years, ABBOTT LABORATORIES received 2 other warning letters from the FDA – 2 of which still unresolved and currently active.
SIGNATURE FORMULATIONS LLC (PHOENIX) received a warning letter on 2026-01-21 based on an inspection on 2025-07-29.
In the last five years, SIGNATURE FORMULATIONS LLC received no other warning letters from the FDA. One more warning letter was issued more than 5 years ago and has not been closed yet.
FINECURE PHARMACEUTICALS LTD (AHMEDABAD) was inspected on 2026-01-14 by EDQM and found GMP non-compliant.
The previous USFDA inspection occured on 2024-11-22, and the site was found to be non-compliant at that time.
WINDER LABORATORIES, LLC (WINDER) received a warning letter on 2026-01-07 based on an inspection on 2025-08-05.
In the last five years, WINDER LABORATORIES, LLC received no other warning letters from the FDA. One more warning letter was issued more than 5 years ago and has not been closed yet.
LATEST WARNING LETTERS AND INSPECTION ALERTS 2025
ABSOLUTELY NATURAL (MELBOURNE) received a warning letter on 2025-12-30 based on an inspection on 2025-04-24.
In the last five years, ABSOLUTELY NATURAL received no other warning letters from the FDA.
CHEMSPEC CHEMICALS PVT LTD (NAVI MUMBAI) received a warning letter on 2025-12-23 based on an inspection on 2025-08-01.
In the last five years, CHEMSPEC CHEMICALS PVT LTD received no other warning letters from the FDA.
TOWER LABORATORIES, LTD (MONTAGUE) received a warning letter on 2025-12-23 based on an inspection on 2025-07-11.
In the last five years, TOWER LABORATORIES, LTD received no other warning letters from the FDA.
UNIPACK S.A (SOUTH PLAINFIELD) received a warning letter on 2025-12-19 based on an inspection on 2025-06-30.
In the last five years, UNIPACK S.A. received no other warning letters from the FDA.
LIQUIDCAPSULE MANUFACTURING LLC (TAMPA) received a warning letter on 2025-12-19 based on an inspection on 2025-07-03.
In the last five years, LIQUIDCAPSULE MANUFACTURING LLC received no other warning letters from the FDA. One more warning letter was issued more than 5 years ago and has not been closed yet.
FAGOFARMA S.R.O. (ROZTOKY) was inspected on 2025-12-16 by EDQM and found GMP non-compliant.
The previous USFDA inspection occured on 2025-11-12, and the site was found to be non-compliant at that time.
HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO. LTD (SHIJIAZHUANG) was inspected on 2025-12-02 by EDQM and found GMP non-compliant.
The previous USFDA inspection occured on 2024-04-05, and the site was found to be non-compliant at that time.
APOTEX INC. (RICHMOND HILL) received a warning letter on 2025-10-31 based on an inspection on 2025-05-09.
In the last five years, APOTEX INC. received no other warning letters from the FDA. 2 warning letters were issued more than 5 years ago and have not been resolved yet.
SCIENTIFIC PROTEIN LABORATORIES (WAUNAKEE) received a warning letter on 2025-10-10 based on an inspection on 2025-05-02.
In the last five years, SCIENTIFIC PROTEIN LABORATORIES received no other warning letters from the FDA.
FOSHAN YIYING HYGIENE PRODUCTS CO., LTD. (NANHAI) received a warning letter on 2025-10-10.
In the last five years, FOSHAN YIYING HYGIENE PRODUCTS CO. LTD received no other warning letters from the FDA.
ACME UNITED CORP. (BROOKSVILLE) received a warning letter on 2025-10-10 based on an inspection on 2025-03-28.
In the last five years, ACME UNITED CORP. received no other warning letters from the FDA.
D P TRADING (LOS ANGELES) received a warning letter on 2025-10-09 based on an inspection on 2025-09-09.
In the last five years, PRODUCE! received 4 other warning letters from the FDA – 5 of which still unresolved and currently active.
SM BIOMED SDN BHD (SUNGAI PETANI) was inspected on 2025-10-08 by EDQM and found GMP non-compliant.
The previous USFDA inspection occured on 2023-07-28, and the site was found to be non-compliant at that time.
GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD (YULIN) received a warning letter on 2025-09-30.
In the last five years, GUANGXI YULIN PHARMACEUTICAL GROUP CO. LTD received no other warning letters from the FDA.
CREATIVE ESSENCES INC (SANTA FE SPRINGS) received a warning letter on 2025-09-25 based on an inspection on 2025-03-25.
In the last five years, CREATIVE ESSENCES INC. received no other warning letters from the FDA.
BRS ANALYTICAL SERVICES LLC (ST. LOUIS) received a warning letter on 2025-09-17 based on an inspection on 2025-03-26.
In the last five years, ANALYTICAL SERVICES, INC. (ASI) received no other warning letters from the FDA.
DIXON INVESTMENTS INC (ORCHARD HILL) received a warning letter on 2025-09-17 based on an inspection on 2025-03-11.
In the last five years, DIXON INVESTMENTS INC. received no other warning letters from the FDA.
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