FDA Inspection
Precision Biometrics, Inc.Precision Biometrics, Inc. – FDA Inspection, Nov 2, 2017
Record Details
This FDA Inspection record concerns Precision Biometrics, Inc., with an inspection on November 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 89caace3-34ce-486d-8a2a-ce845b77f2f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030548
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Precision Biometrics, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 25, 2025 | Not classified | Seattle District Office | |
| December 21, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 10, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 28, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Precision Biometrics, Inc.
- FDA Inspection 1262686 - 2025-02-25
- FDA Inspection 1159509 - 2021-12-21
- FDA Inspection 906948 - 2014-12-10
- FDA Inspection 819950 - 2012-11-28
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