Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

USFDA 483 Cites Piramal Pharma for Inves

Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with

Contamination Control and Data Integrity

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

FDA Issues Warning letter to Chinese API

FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing

Investigation Docs Outside EDMS, Hold Ti

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

Data Integrity issues, Delayed records:

USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site

USFDA 483 to Torrent Pharma cites defici

Torrent’s Chhatral, Gujarat facility (FEI: 3012740315) was inspected by USFDA (Investigator Yvins Dezan) in Dec

US Repackager Spectrum gets USFDA 483 wi

Spectrum Laboratories Inc, New Jersey, USA (FEI 2246824) was inspected by FDA investigators Sayyem H

Warning letter / Centaur / July 2023 / C

Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing

Warning Letter to US Eye Drop Manufactur

The USFDA Warning letter to K. C. Pharmaceuticals issued in August 2023, following inspection at