# Infinium Medical, Inc – FDA Inspection, Nov 8, 2023

Source: https://www.keypedia.com/records/fda_inspections/infinium-medical-inc/c618e370-eb4d-43d7-9341-009b3538a082
Source feed: FDA_Inspections

> FDA inspection 1222370 of Infinium Medical, Inc, November 08, 2023. Classification: Voluntary Action Indicated (VAI). 4 citations under 21 CFR parts 803 and 820. Form 483 issued. 3 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1222370
- Company Name: Infinium Medical, Inc
- Inspection Date: 2023-11-08
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Compliance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 4

## Related Documents

- [FDA Inspection 1089611 - 2019-05-15](https://www.keypedia.com/records/fda_inspections/infinium-medical-inc/fa13fe6c-d988-47f4-a790-1869365d88df)
- FDA Inspection 940638 - 2015-09-04
- FDA Inspection 803436 - 2012-10-15

## Related Officers

- [FDA Associated Person](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/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7