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 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
Breckenridge Pharmaceutical Inc. has announced the recall of over 360,000 bottles of Duloxetine Delayed-Release Capsules
USFDA has announced the Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program for the
WHO has published a comprehensive and easy to understand guideline for control of nitrosamines in
