Warning letters, 483s, Recalls, Import Alerts, Audit observations
Everest Organics Ltd (Telangana, India) was issued a GMP Non-Compliance Report with recommendation to suspend
Sun Pharma Dadra unit (FEI 3004561553) was inspected by USFDA in December 2023 by FDA
USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations.
As expected FDA has taken regulatory action and issued a Warning letter to Natco, following
USFDA Warning letter to Australian API manufacturer cites basic laboratory compliance issues – Inadequate OOS
USFDA inspected Jubilant Generics Limited facility in Roorkee, India, from January 25th to February 2nd,
Chinese API Manufacturer Sichuan Deebio Pharmaceuticals was awarded USFDA 483 with six observations citing Data
FDA issued a Warning letter to Amman Pharmaceuticals following inspection at the facility (FEI 3013501887)
USFDA Inspectors Anders W. Evenson and Arsen Karapetyan had inspected the Sichuan Deebio facility (FEI
Aurobindo arm Eugia Pharma site at Sangareddy, Telengana was inspected by USFDA in Jan -Feb
