Warning letters, 483s, Recalls, Import Alerts, Audit observations
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter in June 2025
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
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 (FEI 3005124189) received a warning letter from the FDA following critical
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
