Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA Inspection of Pharmathen’s Rodopi facility in Greece (FEI 3009961173) resulted in issuance of Form
The USFDA issued a Warning Letter to API manufacturer Chemspec Chemicals (Mumbai) in December 2025,
FDA conducted an inspection at the Hetero Labs Ltd, Warehouse at Nakkapally Village, Vishakapatnam, Andra
Pune based Akriti Pharmaceuticals Private Limited’s EUGMP Certificate remains suspended as the facility remains in
The USFDA inspection of Hetero Labs Ltd, Unit-IX (FEI: 3009093782), Narasapuram, India, conducted in September
Novo Nordisk owned Catalent Indiana sterile products formulation facility was inspected by USFDA in June
The USFDA has issued a Warning Letter to Shiva Analyticals’ Bangalore facility following significant cGMP
Natco Pharma’s sterile products manufacturing facility at Rangareddy, Telengana (FEI 3004540906) was inspected by USFDA
The USFDA issued a notification on 22 May, 2025 on Data Integrity concerns on reliability
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
