Warning letters, 483s, Recalls, Import Alerts, Audit observations
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,
USFDA audit of Eugia US Manufacturing in New Jersey, US (FEI 3015534630) resulted in issuance
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
The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over
Centaur Pharmaceuticals, India issued Warning letter by USFDA. The Warning letter dated 5 June 2023
IPCA Dhar facility was inspected by USFDA in June 2023. The site (FEI 3007574780) was
