FDA 483 - Sanofi Winthrop Industrie - January 26, 2024

Sanofi Pasteur's Val De Reuil facility was cited for significant issues during an FDA inspection, including a failed aseptic process simulation due to mold contamination and subsequent requalification failures for a lyophilizer line used for US-licensed Dengvaxia® vaccine. Additionally, the firm failed to follow its own quality control procedures for deviation initiation, had unsuitable building construction in an aseptic area, and used an automatic visual inspection machine that required manual re-inspection of all rejects despite its qualification. These observations indicate serious deficiencies in aseptic processing, quality system adherence, facility design, and equipment suitability.