FDA 483 - AADCO Medical Inc. - February 22, 2023

AADCO Medical Inc. in Randolph, VT, was inspected by the FDA from February 21-22, 2023, and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality system procedures, including issues with product acceptance status, device history records, design history files, process validation documentation, and design review procedures. These observations indicate a need for improved adherence to medical device quality system regulations.