Qvents

Contamination Control and Data Integrity

Granules India received a warning letter from the USFDA in February 2025. This was along

Janssen’s Korea Vaccine Unit USFDA 483

Janssen’s Korean Vaccine unit Janssen Vaccines Corporation (FEI 3012637764) received an USFDA 483 for critical

Facility Registration Violations, Refusa

Indian API manufacturer Jagsonpal Pharmaceuticals was issued a Warning Letter by the US FDA in

Purified Water System Qualification and

The FDA inspected Colgate-Palmolive/Tom’s of Maine, Inc’s Sanford facility in the US in May 2024.

NDSRIs: Glenmark Recalls Several Lots of

Glenmark Pharmaceuticals is recalling several lots of the cardiovascular drug Carvedilol in US due to

FDA Warning Letter to Viatris: Concerns

FDA has published the Warning Letter issued to the Viatris Pithampur facility in December 2024. This Warning

Growing Trend of Drug Recalls for NDSRIs

Adding to the number of recalls during 2024 for NDSRIs, Ascend (Alkem) is recalling the

Aarti Drugs USFDA 483 Flags Unique Chall

Authored by: Venkiteswaran.T.K, SubrangshuChourdhary, Srinivas Churya, Satish Reddy, Sanjeev Kumar Singh Aarti Drugs API facility in Tarapur, India

API Key SM Source Concerns: Lupin Recall

Authored by: Venkiteswaran.T.K, Subrangshu Chourdhary, Satish Reddy Lupin is recalling over 600,000 bottles of Ramipril capsules across different

Investigation Docs Outside EDMS, Hold Ti

Authored by: Venkiteswaran.T.K, Subrangshu Chourdhary, Srinivas Churya Jubilant Generics Roorkee facility was inspected in January