FDA 483 - Regeneron Pharmaceuticals Inc - October 18, 2019

Regeneron Pharmaceuticals Inc, a biological drug substance manufacturer in Rensselaer, NY, was inspected from October 9-18, 2019. The inspection revealed that the firm's quality control unit failed to fully follow its responsibilities and procedures, specifically by not assessing unexpected events that could affect product safety, purity, or potency for regulatory reporting. This indicates a significant lapse in the firm's quality system regarding deviation management and regulatory compliance.