FDA Inspection
VAX-D Medical Technologies LLCVAX-D Medical Technologies LLC – FDA Inspection, Feb 5, 2013
Record Details
This FDA Inspection record concerns VAX-D Medical Technologies LLC, with an inspection on February 5, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 5, 2013
- Product Type
- Devices
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ID · ffb012e0-3256-4e8a-b6a6-d7322b4919b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 817573
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.180Availability
- 21 CFR 820.184DHR content
- 21 CFR 806.20(b)(2)Device model identification
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
- 21 CFR 820.30(g)Design validation - software validation not performed
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Other FDA inspections of VAX-D Medical Technologies LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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