FDA 483 - Nanovis LLC - March 19, 2026

Nanovis LLC in Columbia City, IN, was inspected by the FDA from March 16-19, 2026, revealing significant deficiencies in their quality management system. The firm failed to adequately validate processes, monitor production controls, and maintain environmental controls for their titanium anodize nano surface treatment. Additionally, issues were noted in purchasing controls, the effectiveness of corrective actions, and the control of changes to manufacturing processes, indicating a lack of robust systems to ensure medical device quality and safety.