Warning letters, 483s, Recalls, Import Alerts, Audit observations
Pune based Akriti Pharmaceuticals Private Limited’s EUGMP Certificate remains suspended as the facility remains in
Natco Pharma’s sterile products manufacturing facility at Rangareddy, Telengana (FEI 3004540906) was inspected by USFDA
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
The USFDA issued a warning letter in January 2025 to Sanofi’s API facility in Framingham,
Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical
Everest Organics Ltd (Telangana, India) was issued a GMP Non-Compliance Report with recommendation to suspend
The USFDA 483 issued to Sun Pharma, Dadra unit in India (FEI 3004561553) published by
FDA issued a Warning letter to Amman Pharmaceuticals following inspection at the facility (FEI 3013501887)
USFDA audit of Eugia US Manufacturing in New Jersey, US (FEI 3015534630) resulted in issuance
The USFDA Warning letter to K. C. Pharmaceuticals issued in August 2023, following inspection at
