FDA 483 - Certified Safety Mfg Inc - May 15, 2025

An FDA inspection of Certified Safety Manufacturing, Inc. in Kansas City, MO, identified significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The company failed to adequately analyze complaint data for trends and did not conduct proper root cause investigations or verify the effectiveness of corrective actions for multiple CAPAs. This is a repeat observation from previous inspections, indicating a persistent lack of compliance.