FDA Inspection
Dr. Adrian DumitrescuDr. Adrian Dumitrescu – FDA Inspection, Dec 6, 2012
Record Details
This FDA Inspection record concerns Dr. Adrian Dumitrescu, with an inspection on December 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dr. Adrian Dumitrescu
- Inspection Date
- December 6, 2012
- Product Type
- Devices
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ID · fc463ffa-654f-4c2f-ab0c-9082cfaef794
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 809847
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 821.20(a)Failure to track
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.180Availability
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of Dr. Adrian Dumitrescu
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 3, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 5, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Dr. Adrian Dumitrescu
- FDA Inspection 905445 - 2014-12-03
- FDA Inspection 628425 - 2009-11-05
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