FDA 483 - Sanofi Pasteur - September 29, 2023

An FDA inspection of Sanofi Pasteur's vaccine manufacturing facility in Marcy-L'Etoile, France, revealed significant deficiencies in manufacturing and quality control. Observations included incomplete master production records for vaccine components, inadequate investigations into product discrepancies, and improper storage conditions for drug products. Additionally, the firm exhibited insufficient laboratory controls and a failure to follow aseptic practices during sterile manufacturing, raising concerns about product quality and sterility.