Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
USFDA issued a Warning letter to Glenmark Facility at Pithampur (FEI 3008565058) in July 2025.
Natco Pharma’s sterile products manufacturing facility at Rangareddy, Telengana (FEI 3004540906) was inspected by USFDA
Accord (Intas) initiated a recall of several lots of Levothyroxine tablets in the US for
Qvents Apps & ToolsNitrosamine and NDSRI Risk Assessment Tools – APIs, Drug Products, Excipients, Water
As per EUGMP requirements, EudraLex, Annex 16: Certification by a Qualified Person and Batch Release,
Author: Venkiteswaran.T.K The USFDA’s 2011 guidance on process validation advocates a life cycle approach and
In March 2025, Glenmark initiated recall of 23 products (148 lots) in US for cGMP
