Warning letters, 483s, Recalls, Import Alerts, Audit observations
According to the EU GMP guidance—“Guidance for Risk Assessment for Ascertaining the Appropriate Good Manufacturing
Authored by: Srinivas Churya This Quality Insight post presents a concise approach for selection and
Authored by: Venkiteswaran.T.K Nitrosamine impurities in pharmaceutical products are a significant concern due to their
Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with
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
Indian API manufacturer Jagsonpal Pharmaceuticals was issued a Warning Letter by the US FDA in
The FDA inspected Colgate-Palmolive/Tom’s of Maine, Inc’s Sanford facility in the US in May 2024.
Glenmark Pharmaceuticals is recalling several lots of the cardiovascular drug Carvedilol in US due to
Authored by: Venkiteswaran.T.K, Srinivas Churya FDA has published the Warning Letter issued to the Viatris Pithampur facility in December
