FDA 483 - Sanofi Pasteur - September 18, 2017

An FDA inspection of Sanofi Pasteur S.A. in Marcy l'Etoile, France, a licensed biological manufacturer, revealed significant deficiencies across multiple critical areas. Issues included an inadequate stability program for rabies vaccine, failures in aseptic processing simulations, and untimely reporting of serious adverse events to VAERS. The firm also exhibited weaknesses in its CAPA system, OOS investigations, visual inspection program, process validation, and personnel gowning practices.