Thermo Fisher Scientific (Asheville) LLC – FDA 483, Aug 26, 2025

During an inspection conducted from August 19 to August 26, 2025, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Thermo Fisher Scientific (Asheville) LLC. The inspection revealed deficiencies in the company’s quality system, specifically regarding its purchasing controls and supplier management processes. The primary observation noted that the company’s procedures for ensuring that purchased products and services meet specified requirements were not adequately established or implemented. The existing corporate supplier quality procedures did not sufficiently address site-specific supplier evaluation. Critical gaps included the lack of documented processes for communicating technical specifications or acceptance criteria to suppliers, and the absence of firm-specific supplier evaluation criteria. Furthermore, the company utilized an unapproved and unqualified contractor for a design change to a Class II Incubator device component, violating its own purchasing control guidelines. These observations indicate non-compliance with the regulatory framework governing medical device manufacturing quality systems, as outlined under the Federal Food, Drug and Cosmetic Act. While a Form FDA 483 is an initial report of observations, it signifies conditions that require corrective action to ensure compliance. Thermo Fisher Scientific (Asheville) LLC is expected to develop and implement robust corrective actions, including revising and enforcing comprehensive supplier qualification, evaluation, and monitoring procedures to address these identified deficiencies.