FDA 483 - Regeneron Pharmaceuticals Inc

An FDA inspection of Regeneron Pharmaceuticals, Inc.'s drug substance manufacturing facility in Rensselaer, NY, revealed significant deficiencies in contamination control and quality assurance. Observations included inadequate physical segregation of activities posing viral contamination risks, insufficient cleaning verification leading to bioburden contamination, and a high percentage of invalidated release and in-process assays. These findings suggest a need for improved controls to ensure product quality and safety.