Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA issued a Form 483 to Strides Pharma Sciences Ltd., Bangalore facility (FEI 3004554612)
The U.S. FDA has issued a Warning Letter to Simtra BioPharma Solutions following cGMP deviations
USFDA has issued a Warning letter to Glenmark Pharma’s Pithampur manufacturing facility (FEI 3008565058). The
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter in June 2025
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
