FDA Inspection
Commonwealth Diagnostics International Inc.Commonwealth Diagnostics International Inc. – FDA Inspection, Mar 15, 2012
Record Details
This FDA Inspection record concerns Commonwealth Diagnostics International Inc., with an inspection on March 15, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 15, 2012
- Product Type
- Devices
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ID · aa9378c3-879b-4d2e-8dd4-8b8cc0d34489
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 773983
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.20(d)Quality plan
- 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
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Other FDA inspections of Commonwealth Diagnostics International Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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