Warning letters, 483s, Recalls, Import Alerts, Audit observations
Zydus is recalling multiple lots of the antipsychotic drug Chlorpromazine in U.S due to the
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
Qvents Apps & Tools Access the Excipient Risk Assessment Tool – Click Here According to
Authored by: Srinivas Churya This Quality Insight post presents a concise approach for selection and
Granules India received a warning letter from the USFDA in February 2025. This was along
Janssen’s Korean Vaccine unit Janssen Vaccines Corporation (FEI 3012637764) received an USFDA 483 for critical
