FDA 483 - 3B Medical, Inc. - December 10, 2025

An FDA inspection of 3B Medical, Inc. in Dublin, OH, revealed significant deficiencies across multiple quality system areas for medical devices. The firm's complaint handling, corrective and preventive action (CAPA) procedures, risk analysis, design history file maintenance, employee training, and management review processes were all found to be inadequate. These issues indicate a lack of robust controls necessary for ensuring product quality and regulatory compliance.