FDA 483 - Koning Corporation - July 21, 2025

An FDA inspection of Koning Corporation in Norcross, GA, a manufacturer of Class III medical devices, revealed two significant observations. The firm failed to ensure its Koning Breast CT device labels bore a Unique Device Identifier (UDI) and did not provide the required device information to the Global Unique Device Identification Database (GUDID). These issues indicate non-compliance with medical device identification and registration regulations.