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

During an FDA inspection conducted from November 7-8, 2023, at Infinium Medical, Inc., a medical device manufacturer located at 12151 62nd St Ste 5, Largo, FL 33773-3702, two observations were made and issued to President Mr. Oz Ozkaya.

Observation 1 noted that service requests representing Medical Device Report (MDR) reportable events were not automatically considered complaints and processed per 21 CFR 820.198. Specifically, Service Request SR 2023-0019, reported March 1, 2023, regarding an OMNI K Monitor malfunction during patient oral surgery, was not escalated to a customer complaint despite the firm's "Service Process" procedure (DOC # QP-31, Version 1, Effective Date 7/10/2023) requiring immediate notification to the Director of QA for escalation if a device malfunction could result in death or serious injury.

Observation 2 indicated that an MDR report was not submitted within 30 days of becoming aware of information suggesting a marketed device malfunction that would likely cause or contribute to death or serious injury if it recurred. This specifically refers to the OMNI K Monitor malfunction reported on March 1, 2023, via Service Report SR 2023-0019