FDA 483 - REACT Innovations - February 17, 2023

An FDA inspection of Magic Race, LLC, a manufacturer in Charlotte, NC, revealed significant deficiencies in its quality system. The firm failed to establish numerous essential procedures, including those for Medical Device Reporting, complaint handling, purchasing controls, corrective and preventive actions, installation, supplier evaluation, quality audits, and management review. These observations indicate a fundamental lack of a documented and implemented quality system.