Warning letters, 483s, Recalls, Import Alerts, Audit observations
Unichem Pharmaceuticals (USA), Inc. initiated a recall of Bisoprolol fumarate and Hydrochlorothiazide tablets in the
Qvents provides useful tools for QMS processes – Risk Assessments, Continuous Process Validations, Supply Chain Traceability
Zydus is recalling multiple lots of the antipsychotic drug Chlorpromazine in U.S due to the
Alembic recently initiated recall of antidepressant drug Doxepin Hydrochloride Capsules (10 mg) in US for Nitrosamine
USFDA has allowed drug manufacturers additional time for submission of mitigation actions and required changes
Qvents Apps & ToolsNitrosamine and NDSRI Risk Assessment Tools – APIs, Drug Products, Excipients, Water
Breckenridge Pharmaceutical Inc. has announced the recall of over 360,000 bottles of Duloxetine Delayed-Release Capsules
WHO has published a comprehensive and easy to understand guideline for control of nitrosamines in
First Recall of Diphenhydramine HCl for NDSRI With timelines closing in for drug product manufacturers
Glenmark Pharmaceuticals has initiated a recall of over 1.5 million bottles of their ADHD medication,
