Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
The Central Drugs Standard Control Organisation (CDSCO) has published the NSQ (Not of Standard Quality)
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
Indian drug regulatory, CDSCO has notified the new online Export NOC system for Unapproved Drugs
