FDA 483 - QED, Inc. - April 11, 2025

QED, Inc. in Lexington, KY, was inspected by the FDA from April 7-11, 2025, and received a Form 483 with two observations. The inspection revealed significant non-compliance regarding Unique Device Identification (UDI) requirements. Specifically, the firm failed to register several medical devices in the GUDID database and did not include UDIs on the labels of these devices.