FDA 483 - Thermo Fisher Scientific (Asheville) LLC - August 26, 2025

During an inspection, the FDA cited Thermo Fisher Scientific (Asheville) LLC in Marietta, OH, for inadequate purchasing controls and supplier evaluation procedures. The firm failed to establish proper processes for communicating technical specifications to suppliers and for formally approving and qualifying contractors involved in device component design changes. These deficiencies indicate a significant lapse in ensuring purchased products and services conform to specified requirements.