FDA 483 - Sanofi Pasteur Inc. - January 26, 2024

The FDA conducted an inspection at a facility in Val de Reuil, associated with Site Head Henri Lanfry, from January 18 to January 26, 2024. The inspection revealed several significant compliance issues, particularly concerning the manufacturing of the US-licensed vaccine, Dengvaxia, indicating a need for adherence to current Good Manufacturing Practices (cGMP). A primary concern was the inadequate validation of the aseptic process. The firm failed multiple aseptic process simulations (APS) for a Lyophilizer Line, with one instance directly linked to mold contamination (Engyodontium album) in a simulated product vial. The facility was unable to complete three consecutive successful APS runs to re-qualify the critical sterile manufacturing line, highlighting a severe control deficiency. Additional observations included systemic failures within the quality control unit, such as not initiating 12 out of 30 reviewed deviations within the required one-day discovery timeframe. Facility construction also presented issues, with damaged and inconsistent flooring identified in a critical aseptic manufacturing area for Dengvaxia, lacking appropriate risk assessment or environmental monitoring. Furthermore, equipment used for visual inspection of Dengvaxia displayed discrepancies between its requalification acceptance criteria and the firm’s standard operating procedures. The company is expected to implement thorough corrective actions to address these observations and ensure compliance with regulatory standards.