Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA has published over 200+ redacted Complete Response Letters (CRLs) issued to drug applicants. The
USFDA has allowed drug manufacturers additional time for submission of mitigation actions and required changes
USFDA has issued the final guidance for Pre-Submission Facility Correspondence (PFC) for prioritised generic drug
The USFDA issued a notification on 22 May, 2025 on Data Integrity concerns on reliability
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment
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 FDA has issued new guidance on “Considerations for Complying With 21 CFR 211.110.” According
Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical
