FDA 483 - Overture Resurfacing Inc. DBA Overture Orthopaedics - January 30, 2025

Overture Resurfacing Inc. DBA Overture Orthopaedics in Irvine, CA, was inspected by the FDA from January 23-30, 2025. The inspection revealed a significant issue regarding the firm's purchasing controls. Specifically, the company failed to establish adequate agreements with critical suppliers for its Class II Knee Resurfacing System device, despite its own procedures requiring such agreements.