FDA 483 - Halo Medical Technologies - May 23, 2022

Halo Medical Technologies in Bethlehem, PA, a medical device manufacturer, was inspected by the FDA from May 18-23, 2022. The inspection revealed one significant observation concerning the firm's failure to develop and implement written Medical Device Reporting (MDR) procedures. This indicates a critical lapse in their system for evaluating medical device-related adverse events.