FDA Inspection
Imaging Biometrics LLCImaging Biometrics LLC – FDA Inspection, Mar 22, 2013
Record Details
This FDA Inspection record concerns Imaging Biometrics LLC, with an inspection on March 22, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Imaging Biometrics LLC
- Inspection Date
- March 22, 2013
- Product Type
- Devices
View Company Profile
ID · faf48e43-e4cd-4753-a2b3-b7653c200c69
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 824133
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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 |
| October 12, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1069058 - 2018-10-12
- FDA Inspection 669353 - 2010-06-24
- FDA Inspection 615376 - 2009-09-30
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