FDA 483 - Sanofi Pasteur - September 27, 2017

An FDA inspection conducted from September 18-27, 2017, at Sanofi Pasteur S.A. in Marcy l'Etoile, France, a licensed biological manufacturer, revealed multiple issues requiring corrective action. The observations included significant deficiencies in the stability program for their rabies vaccine, such as untimely testing, incorrect sample storage, and inadequate interpretation of out-of-specification results. Furthermore, the facility's aseptic processing procedures were found lacking, specifically in the media fill program, which showed weaknesses in representative personnel qualification, critical parameter documentation, and comprehensive growth promotion testing for sterile products. The company also failed to timely report serious adverse events to the Vaccine Adverse Event Reporting System (VAERS), experiencing considerable delays due to initial misclassification. The inspection also highlighted an inadequate application of corrective and preventive actions (CAPA) for notable deviations, including the presence of foreign particles in vials and recurring equipment failures. Investigations into out-of-specification events were often prolonged, lacked thorough root cause identification, or lacked supporting data. Deficiencies were noted in the visual inspection program for finished products, concerning inspector qualification and defect characterization. Finally, lapses in personnel gowning procedures in critical manufacturing areas and unvalidated process hold times underscored the need for improved adherence to good manufacturing practices.