Warning letters, 483s, Recalls, Import Alerts, Audit observations
Unichem Pharmaceuticals (USA), Inc. initiated a recall of Bisoprolol fumarate and Hydrochlorothiazide tablets in the
USFDA Inspection of Pharmathen’s Rodopi facility in Greece (FEI 3009961173) resulted in issuance of Form
Imprimis NJOF recalled three intraocular ophthalmic injection drug products in December 2025 (as per USFDA
Qvents provides useful tools for QMS processes – Risk Assessments, Continuous Process Validations, Supply Chain Traceability
In November 2025, the USFDA issued a Warning Letter to Bangalore-based Cdymax India following an
The USFDA inspection of Hetero Labs Ltd, Unit-IX (FEI: 3009093782), Narasapuram, India, conducted in September
Zydus is recalling multiple lots of the antipsychotic drug Chlorpromazine in U.S due to the
The USFDA issued a Warning letter to Hikal’s API facility in Jigani, Bangalore, India. The
Alembic recently initiated recall of antidepressant drug Doxepin Hydrochloride Capsules (10 mg) in US for Nitrosamine
The USFDA has issued a Warning Letter to Shiva Analyticals’ Bangalore facility following significant cGMP
