FDA 483 - Sanofi Winthrop Industrie

An FDA inspection of Genzyme Polyclonals SAS in Lyon, France, a drug substance manufacturer, revealed significant deficiencies across multiple areas. The firm was cited for inadequate data integrity controls, including issues with second-person review, computerized system verification, and unauthorized file manipulation. Additionally, the inspection found that the Quality Assurance unit failed to effectively investigate deviations and that environmental monitoring procedures were deficient, alongside issues with equipment design and adherence to product specifications.