FDA 483 - Regeneron Pharmaceuticals, Inc. - January 16, 2026

An FDA inspection of Regeneron Pharmaceuticals, Inc. in East Greenbush, NY, revealed significant deficiencies in their sterile drug product manufacturing processes. Observations included failures in preventing microbiological contamination, inadequate environmental monitoring in aseptic processing areas, and non-adherence to standard operating procedures. These issues raise concerns about the sterility assurance and overall quality control at the facility.