FDA 483 - SPOT HEALTH INC - October 22, 2025

An FDA inspection of SPOT HEALTH INC, a medical device manufacturer in Cincinnati, OH, revealed significant deficiencies in their quality system. Observations included failures in maintaining complaint files with MDR evaluations, not initiating corrective and preventive actions for quality system changes, and lacking a designated management representative. Additionally, the firm's medical device labels did not include a Unique Device Identifier (UDI).