FDA Inspection
Phoenix Diagnostics, Inc.Phoenix Diagnostics, Inc. – FDA Inspection, Aug 18, 2017
Record Details
This FDA Inspection record concerns Phoenix Diagnostics, Inc., with an inspection on August 18, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fd34080b-275f-46d4-9da2-a471a13af3b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022108
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Phoenix Diagnostics, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 26, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 6, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Phoenix Diagnostics, Inc.
- FDA Inspection 1164713 - 2022-03-17
- FDA Inspection 792557 - 2012-07-26
- FDA Inspection 602295 - 2009-08-06
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