Warning letters, 483s, Recalls, Import Alerts, Audit 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
The USFDA 483 issued to Sichuan Deebio Pharmaceutical Co. Ltd cite critical data integrity observations
FDA inspected the Drug Testing Establishment of DRL (Dr.Reddy’s Laboratories) at Bachupally, Telengana India (FEI:3009483004)
USFDA issued a Warning letter to Intas, Matoda, Ahmedabad facility (FEI 3003157498) on 21 November
