FDA 483 - Infinium Medical, Inc - November 08, 2023

Infinium Medical, Inc. in Largo, FL, was inspected by the FDA from November 1 to November 8, 2023. The inspection revealed significant issues with the firm's complaint handling and medical device reporting processes. Specifically, the firm failed to properly escalate service requests to complaints and did not submit a required Medical Device Report within the mandated timeframe for a malfunctioning OMNI K Monitor.