FDA 483 - Regeneron Pharmaceuticals Inc - March 22, 2024

An FDA inspection of Regeneron Pharmaceuticals Inc. in Rensselaer, NY, identified a significant deficiency in their quality system. The firm lacked written procedures for production and process controls, specifically concerning a Process Performance Qualification study for drug product formulation. This indicates a failure to ensure drug products consistently meet identity, strength, quality, and purity standards.