FDA 483 - Sanofi Winthrop Industrie - November 17, 2023

An FDA inspection of Sanofi Winthrop Industrie, a biologic drug substance manufacturer in Lyon, France, revealed significant deficiencies across multiple areas. The firm failed to thoroughly investigate laboratory discrepancies, maintain adequate equipment cleaning procedures, and implement effective corrective and preventive actions for environmental monitoring excursions. Additionally, the inspection noted a lack of records for equipment decontamination and poor facility and equipment maintenance leading to potential contamination.