FDA 483 - Cutting Edge Spine - February 02, 2023

An FDA inspection of Cutting Edge Spine in Mineral Springs, NC, from January 30 to February 2, 2023, revealed a significant issue with the firm's quality system. The company failed to adequately establish and follow procedures for evaluating suppliers, specifically lacking documentation to demonstrate that suppliers were assessed according to their own established SOPs. This indicates a breakdown in ensuring purchased products and services meet specified requirements.