FDA Inspection
Phoenix DeventuresPhoenix Deventures – FDA Inspection, Feb 15, 2023
Record Details
This FDA Inspection record concerns Phoenix Deventures, with an inspection on February 15, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Jeffrey S. Buckser
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ID · 42ae32a4-1f45-43e6-ad17-e74aef307f9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1198537
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.20(b)(3)(i)Management representative implementing the quality system
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
- 21 CFR 820.72(a)Equipment control activity documentation
Showing 10 of 12 citations.
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Other FDA inspections of Phoenix Deventures
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 4, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 6, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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