FDA 483 - Cirtec Medical Corporation - February 25, 2021

An FDA inspection of Cirtec Medical Corporation in Brooklyn Park, MN, revealed significant deficiencies in their corrective and preventive action (CAPA) procedures. The firm failed to adequately verify the effectiveness of corrective actions for complaints and CAPAs, and did not follow its own procedures for submitting extension requests for overdue CAPAs. These issues indicate a breakdown in the quality system for ensuring device safety and effectiveness.