FDA Inspection
Infinium Medical, IncInfinium Medical, Inc – FDA Inspection, May 15, 2019
Record Details
This FDA Inspection record concerns Infinium Medical, Inc, with an inspection on May 15, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fa13fe6c-d988-47f4-a790-1869365d88df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089611
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Infinium Medical, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2023 | 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 1222370 - 2023-11-08
- FDA Inspection 940638 - 2015-09-04
- FDA Inspection 803436 - 2012-10-15
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