FDA 483 - Sanofi Pasteur - September 29, 2023

An FDA inspection conducted at Sanofi Pasteur's vaccine manufacturing facility in Marcy-l'Etoile, France, from September 18-29, 2023, resulted in the issuance of an FDA Form 483. The inspection highlighted several critical observations under the Federal Food, Drug, and Cosmetic Act concerning manufacturing and quality control practices. Key issues included deficient master production and control records, specifically for Concentrated Tetanus Protein (CTP) bulk preparation, lacking defined time frames and validated mixing processes. Investigations into product discrepancies, such as cellulose particles in vaccine vials and lost vials during aseptic processing, were found to be incomplete, lacking effectiveness checks for corrective actions or preventive measures. Furthermore, drug products, like WFI diluent, were observed to be stored improperly with dislodged lids and under a condensation unit, risking contamination. Laboratory controls were deemed inadequate due to the absence of reference standards in critical test assays. Finally, procedures to prevent microbiological contamination were not consistently followed, with operators in sterile filling areas observed disrupting controlled environments. Sanofi Pasteur is required to address these observations with comprehensive corrective and preventive actions.