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FDA Inspection
•Dr. Adrian Dumitrescu•December 3, 2014

Dr. Adrian Dumitrescu – FDA Inspection, Dec 3, 2014

Record Details

This FDA Inspection record concerns Dr. Adrian Dumitrescu, with an inspection on December 3, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company
Dr. Adrian Dumitrescu
Inspection Date
December 3, 2014
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 32b2e428-ed9f-4be6-9b11-4517cfc8e761

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
905445
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

5
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  3. 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
  4. 21 CFR 820.50(a)(1)Documented evaluation
  5. 21 CFR 820.50(a)(2)Supplier oversight

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Dr. Adrian Dumitrescu

2
DateClassificationOfficeProject area
December 6, 2012VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
November 5, 2009VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Dr. Adrian Dumitrescu
  • FDA Inspection 809847 - 2012-12-06
  • FDA Inspection 628425 - 2009-11-05

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