FDA 483 - CooperSurgical, Inc. - February 01, 2024

CooperSurgical, Inc. in North Tonawanda, NY, a manufacturer of drug/medical device combination products, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures, including inadequate investigations and lack of verification for corrective actions. Additionally, the firm failed to adequately validate its pouch sealing process, lacking proper statistical rationale for sample sizes.