Warning letters, 483s, Recalls, Import Alerts, Audit observations
Sun Pharma Dadra unit was inspected by USFDA in December 2023 by FDA investigator Pratik
USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations.
USFDA inspection of Cipla, Patalganga site manufacturing APIs and Tablets resulted in USFDA 483 with
As expected FDA has taken regulatory action and issued a Warning letter to Natco, following
USFDA inspected Jubilant Generics Limited facility in Roorkee, India, from January 25th to February 2nd,
The DRL site was inspected by USFDA (Investigators Saleem A Akhtar & Pratik S Upadhyay)
Natco Pharma (india) Kothur facility was inspected by USFDA (Investigators Pratik S. Upadhyay and Saleem
Natco Pharma (india) Kothur facility was inspected by USFDA in October 2023. The site (FEI
Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing
Centaur Pharmaceuticals, India issued Warning letter by USFDA. The Warning letter dated 5 June 2023
