FDA Inspection
Imaging Biometrics LLCImaging Biometrics LLC – FDA Inspection, Oct 12, 2018
Record Details
This FDA Inspection record concerns Imaging Biometrics LLC, with an inspection on October 12, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cb359e64-1fb3-4fd1-a038-feee59f6e610
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069058
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Imaging Biometrics LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2025 | Not classified | Minneapolis District Office | |
| June 9, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 22, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 30, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Imaging Biometrics LLC
- FDA Inspection 1264124 - 2025-03-17
- FDA Inspection 1171915 - 2022-06-09
- FDA Inspection 824133 - 2013-03-22
- FDA Inspection 669353 - 2010-06-24
- FDA Inspection 615376 - 2009-09-30
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