FDA 483 - TRUMEDX LLC - June 26, 2025

An FDA inspection of TRUMEDX LLC in Shelton, CT, an initial importer of medical devices, revealed two significant observations. The firm failed to establish procedures for corrective and preventive actions and did not register the Unique Device Identifiers (UDIs) for its Class I and Class II medical devices in the Global Unique Device Identification Database (GUDID). These issues indicate a lack of adherence to quality system and device identification regulations.