Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA has allowed drug manufacturers additional time for submission of mitigation actions and required changes
Indian drug regulator CDSCO has published the Not of Standard Quality (NSQ) alert lists for
USFDA has issued the final guidance for Pre-Submission Facility Correspondence (PFC) for prioritised generic drug
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter in June 2025
The USFDA issued a notification on 22 May, 2025 on Data Integrity concerns on reliability
Indian regulatory agency, CDSCO has updated the requirements for application and issuance of Export NOC
The Drugs Technical Advisory Board (DTAB) in India has recommended for amendment of Drug Rules
Indian drug regulator CDSCO (Central Drugs Standards Control Organisation) has published the Not of Standard
Cronus Pharma LLC on behalf of Cronus Pharma Specialties, Hyderabad, India initiated a recall of
USFDA 483 issued to Glenmark Pharma’s Pithampur facility (FEI: 3008565058) in India flagged critical deviations
