FDA 483 - Unik Orthopedics, Inc - March 13, 2026

Unik Orthopedics, Inc. in San Jose, CA, a manufacturer of orthopedic devices, received a Form FDA 483 with seven observations during an inspection from March 10-13, 2026. The inspection revealed significant deficiencies across its quality management system, including inadequate documentation for risk management, corrective actions, management review, internal audits, supplier controls, complaint investigations, and product identification. These issues indicate a systemic failure to maintain an effective quality system for medical devices.