FDA 483 - Resolution Biomedical Inc - November 19, 2025

An FDA inspection of Resolution Biomedical Inc, a repackager in Tustin, CA, revealed significant quality system deficiencies. The firm was cited for inadequately established corrective and preventive action procedures, including insufficient investigations and effectiveness verification, which was a repeat observation. Additionally, personnel lacked necessary training for their job functions, and the firm failed to register its products, including a Class II device, in the Global Unique Device Identification Database (GUDID).