Warning letters, 483s, Recalls, Import Alerts, Audit observations
The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP
Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in
FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing
The USFDA issued a warning letter in January 2025 to Sanofi’s API facility in Framingham,
Indoco Remedies’ Goa Plant received a warning letter from the FDA following critical observations during
The USFDA has issued a Warning Letter to Hyderabad-based OTC manufacturer Akron Formulations for critical
New Delhi based Unexo Life Sciences has initiated a major recall of several medicated patch
Chinese OTC Manufacturer Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd was inspected by USFDA in March
Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,
As expected FDA has taken regulatory action and issued a Warning letter to Natco, following
