FDA 483 - Sanofi Pasteur - September 18, 2017
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 6d998153-5531-4e1b-90d5-4124927dcb02