TriRx Medical, LLC – FDA 483, Mar 6, 2026

An FDA inspection of TriRx Medical, LLC in Naples, FL, a manufacturer of orthopedic external fixation medical devices, revealed significant deficiencies in its quality management system. The firm failed to adequately apply a risk-based approach, validate critical manufacturing processes, and maintain proper records for nonconforming products and final inspections. These issues indicate a lack of robust controls over device safety, performance, and regulatory compliance.