Regeneron Pharmaceuticals Inc – FDA EIR, Jun 8, 2018

An FDA pre-license inspection of Regeneron Pharmaceuticals, Inc. in Rensselaer, NY, was conducted from June 4th to June 8th, 2018. The inspection aimed to support the approval of a specific drug substance manufactured at the facility for therapeutic use. The regulatory framework for this risk-based inspection included FDA Compliance Programs 7356.002M for Licensed Therapeutic Drug Products, 7346.832 for Pre-Approval Inspections/Investigations, and ICH Q7 guidelines. The assessment comprehensively reviewed the company’s Quality, Facilities and equipment, Production, Materials, and Laboratories systems. Crucially, the inspection identified no significant deficiencies. Consequently, the FDA did not issue a Form FDA-483, which is typically used to document objectionable conditions. The overall conclusion of the inspection was "No Action Indicated (NAI)," signifying a satisfactory outcome without formal regulatory findings. While no violations or formal issues were documented, two verbal observations were communicated to the firm's management during the closeout meeting. However, the document does not specify any formal required actions following these discussions, indicating that no mandated corrective measures were imposed by the FDA based on this inspection.