FDA 483 - Orthofix U.S. LLC - March 17, 2023

An FDA inspection of Orthofix U.S. LLC in Lewisville, TX, revealed significant deficiencies in their quality system. The firm failed to adequately evaluate and investigate customer complaints for their Class III AccelStim Bone Growth Stimulator, even when device failures were reported. Additionally, the company's corrective and preventive action (CAPA) procedures were not adequately established, leading to a lack of investigation into numerous device issues.