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 has escalated the OAI (Official Action Indicated) classification of the Novo Nordisk–owned Catalent
In September 2025, the USFDA classified Sun Pharmaceutical Industries Ltd.’s Halol facility as OAI (Official
The USFDA issued a Warning letter to Amneal Pharmaceuticals following critical deviations observed during an
USFDA issued a Warning letter to Intas, Matoda, Ahmedabad facility (FEI 3003157498) on 21 November
USFDA483 to Intas cites manipulated visual inspection reports; failure to characterise particles observed in injection
FDA published the USFDA483 issued to Intas site (FEI 3003157498) in Ahmedabad, India after inspection
