FDA 483 - UMI Intl - October 20, 2022

UMI Intl, an importer in East Rutherford, NJ, was inspected by the FDA from October 17-20, 2022. The inspection revealed two significant issues: a lack of documented acceptance or rejection for incoming products like collimators and X-ray grids, and the absence of written Medical Device Reporting (MDR) procedures that include provisions for evaluating complaints for potential serious injury or death. These observations indicate deficiencies in quality system controls and regulatory compliance.