FDA 483 - Regeneron Pharmaceuticals Inc - October 25, 2021

Regeneron Pharmaceuticals Inc. in Rensselaer, NY, was inspected and received a Form 483 with six observations. The inspection revealed significant deficiencies in complaint handling and investigation procedures, including failure to investigate numerous complaints and delays in closing others. Additionally, the firm's aseptic processing controls were found inadequate, with issues in process validation, adherence to aseptic techniques, and cleaning/disinfection protocols, alongside delayed reporting of biological product deviations.