FDA 483 - Orchid Orthopedic Solutions, LLC - June 18, 2025

An FDA inspection of Orchid Orthopedic Solutions, LLC in Holt, MI, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, specifically regarding risk determination for verification of effectiveness and proper CAPA follow-up. Additionally, nonconforming products were not adequately controlled, as several nonconforming material reports were closed without documenting root causes.