FDA 483 - Regeneron Pharmaceuticals Inc - October 25, 2021
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.
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.
ID · 5edf66c0-5435-47f5-8b9c-95bb5b5aa87c