FDA 483 - Focalyx Technologies - December 01, 2025

Focalx Technologies, LLC, a medical device manufacturer in Hialeah, FL, was cited for two significant observations during an FDA inspection. The firm failed to adequately verify and validate its Class II medical device software for compatibility with an upgraded operating system. Additionally, the company did not ensure its medical device labels bore a unique device identifier (UDI) and failed to submit required information to the Global Unique Device Identification Database (GUDID).