FDA 483 - Sanofi Winthrop Industrie

Sanofi Winthrop Industrie, a vaccines and pharmaceutical drugs manufacturer in Le Trait, France, was inspected by the FDA from May 16-25, 2018. The inspection revealed significant deficiencies across aseptic processing, environmental monitoring, equipment maintenance, media fill procedures, material storage, packaging line clearance, personnel training, complaint handling, CAPA management, and OOS procedures. These issues indicate a systemic lack of control over critical manufacturing processes and quality systems, posing potential risks to drug product quality and sterility.