FDA Inspection
Phoenix Medical Devices, LLCPhoenix Medical Devices, LLC – FDA Inspection, May 13, 2009
Record Details
This FDA Inspection record concerns Phoenix Medical Devices, LLC, with an inspection on May 13, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Phoenix Medical Devices, LLC
- Inspection Date
- May 13, 2009
- Product Type
- Devices
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ID · c9d36a1e-12d6-4c17-a27a-93cf3e30b8bd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 583676
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
19- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.25(b)Training records
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.80(b)Incoming inspection, testing, verification
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of Phoenix Medical Devices, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Phoenix Medical Devices, LLC
- FDA Inspection 733937 - 2011-06-24
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