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

Source: https://www.keypedia.com/records/483/infinium-medical-inc/7eca65f0-bc33-4620-8811-d60eab439c76

> FDA 483 for Infinium Medical, Inc on November 08, 2023. Product: device. 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: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Documents

- [483 - 2023-11-08](https://www.keypedia.com/records/483/infinium-medical-inc/279430c3-812c-4d88-b130-036b447a220e)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6