FDA 483 - SpineSmith Holdings, LLC - February 13, 2026

An FDA inspection of SpineSmith Holdings, LLC in Austin, TX, a manufacturer of Class II medical devices, revealed significant deficiencies in product realization planning and control of purchased products. The firm failed to adequately define quality objectives and acceptance criteria for its medical devices, leading to numerous heating-related complaints. Additionally, the company did not properly establish and implement activities to ensure purchased medical devices met specified requirements, particularly concerning sterility and electrical performance testing.