Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA 483 issued to Glenmark Pharma’s Pithampur facility (FEI: 3008565058) in India flagged critical deviations
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
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
FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing
Authored by: Venkiteswaran.T.K, Subrangshu Chourdhary, Srinivas Churya Jubilant Generics Roorkee facility was inspected in January
USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site
Torrent’s Chhatral, Gujarat facility (FEI: 3012740315) was inspected by USFDA (Investigator Yvins Dezan) in Dec
Spectrum Laboratories Inc, New Jersey, USA (FEI 2246824) was inspected by FDA investigators Sayyem H
Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing
