FDA 483 - Engineered Endodontics, LLC - August 28, 2025

Engineered Endodontics, LLC, a repackager/relabeler in Menomonee Falls, WI, was inspected by the FDA. The inspection revealed one observation related to the firm's failure to submit correct unique device identifier (UDI) information for its registered Class I and Class II devices to the Global Unique Device Identification Database (GUDID). This indicates a compliance issue with device identification data submission requirements.