CooperSurgical, Inc. – FDA 483, Mar 24, 2026

An FDA inspection of CooperSurgical, Inc. in North Tonawanda, NY, a manufacturer of drug/medical device combination products, revealed nine significant observations, including repeat issues from a previous inspection. The firm was cited for inadequate complaint investigations, failures in discrepancy reviews, deficiencies in production and process controls, and insufficient laboratory controls. Other critical findings involved improper equipment calibration and qualification, unqualified suppliers, inadequate reserve sample examinations, and poorly documented risk management and purchasing procedures.