FDA Inspection
VAX-D Medical Technologies LLCVAX-D Medical Technologies LLC – FDA Inspection, Apr 13, 2012
Record Details
This FDA Inspection record concerns VAX-D Medical Technologies LLC, with an inspection on April 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 13, 2012
- Product Type
- Devices
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ID · aadb7654-1981-403a-9330-b2ec46803ad0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 776703
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.184DHR content
- 21 CFR 806.20(b)(2)Device model identification
Showing 10 of 12 citations.
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Other FDA inspections of VAX-D Medical Technologies LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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