FDA Inspection
Infinium Medical, IncInfinium Medical, Inc – FDA Inspection, Nov 8, 2023
Record Details
This FDA Inspection record concerns Infinium Medical, Inc, with an inspection on November 8, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c618e370-eb4d-43d7-9341-009b3538a082
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1222370
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.200(c)Service reports/MDRs/complaints
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.200(c)Service reports/MDRs/complaints
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Other FDA inspections of Infinium Medical, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 4, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 15, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Infinium Medical, Inc
- FDA Inspection 1089611 - 2019-05-15
- FDA Inspection 940638 - 2015-09-04
- FDA Inspection 803436 - 2012-10-15
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