FDA 483 - ZMICRO, INC. - October 16, 2025

An FDA inspection of ZMICRO, INC., conducted from October 14 to October 16, 2025, identified a significant compliance issue. The primary observation noted that the company failed to provide the correct unique device identifier (UDI) information for one of its medical devices to the Food and Drug Administration's Global Unique Device Identification Database (GUDID). Specifically, the Unique Device Identifier for the Meridiem Image Enhancer, a Class II video enhancement system, was not registered in the GUDID as required by federal regulations. This constitutes a violation of the regulatory framework governing medical device identification. Following the inspection, ZMICRO, INC. is expected to address this observation by either discussing any objections with the FDA or implementing and submitting a plan for corrective actions to ensure full compliance with UDI submission requirements. The FDA emphasizes that the firm is responsible for conducting internal self-audits to identify and rectify all quality system violations.