Warning letters, 483s, Recalls, Import Alerts, Audit observations
The U.S. FDA has issued a Warning Letter to Simtra BioPharma Solutions following cGMP deviations
USFDA Inspection of Pharmathen’s Rodopi facility in Greece (FEI 3009961173) resulted in issuance of Form
The USFDA has classified Sun Pharma’s Baska (Halol) facility (FEI: 3002957541) as Official Action Indicated
An USFDA 483 to CDMO major Catalent’s Baltimore facility (FEI 3015558590) in US cite poor
FDA has published the USFDA Form 483 issued to sterile drug manufacturing facility of Fareva
In September 2025, the USFDA classified Sun Pharmaceutical Industries Ltd.’s Halol facility as OAI (Official
Novo Nordisk owned Catalent Indiana sterile products formulation facility was inspected by USFDA in June
Natco Pharma’s sterile products manufacturing facility at Rangareddy, Telengana (FEI 3004540906) was inspected by USFDA
Janssen’s Korean Vaccine unit Janssen Vaccines Corporation (FEI 3012637764) received an USFDA 483 for critical
Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical
