Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA issued a Warning Letter to API manufacturer Chemspec Chemicals (Mumbai) in December 2025,
The USFDA has escalated the OAI (Official Action Indicated) classification of the Novo Nordisk–owned Catalent
Janssen Vaccines Corp., a Johnson & Johnson company operating in Korea, was issued an FDA
The USFDA issued a Warning letter to Amneal Pharmaceuticals following critical deviations observed during an
USFDA has issued a Warning letter to Glenmark Pharma’s Pithampur manufacturing facility (FEI 3008565058). The
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
