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

Source: https://www.globalkeysolutions.net/records/483/infinium-medical-inc/279430c3-812c-4d88-b130-036b447a220e

> FDA 483 for Infinium Medical, Inc on November 08, 2023. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Infinium Medical, Inc
- Inspection Date: 2023-11-08
- Product Type: Devices
- Office Name: Florida District Office
- Summary: 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

## Related Documents

- [483 - 2023-11-08](https://www.globalkeysolutions.net/records/483/infinium-medical-inc/7eca65f0-bc33-4620-8811-d60eab439c76)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/suzanne-m-healy/a4159f42-8968-4dec-89e3-46a5412bc47a)

Company: https://www.globalkeysolutions.net/companies/infinium-medical-inc/1f45c91a-6415-4a90-b598-8eef5c6f33e6

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9