FDA Inspection
Phoenix Diagnostics, Inc.Phoenix Diagnostics, Inc. – FDA Inspection, Jul 26, 2012
Record Details
This FDA Inspection record concerns Phoenix Diagnostics, Inc., with an inspection on July 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Phoenix Diagnostics, Inc.
- Inspection Date
- July 26, 2012
- Product Type
- Devices
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ID · dacd52aa-c5f5-4638-bb09-78dadfdc6e09
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 792557
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
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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 |
| August 18, 2017 | 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 1022108 - 2017-08-18
- FDA Inspection 602295 - 2009-08-06
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