FDA Inspection
Fayez E. Shamoon, M.D.Fayez E. Shamoon, M.D. – FDA Inspection, Mar 20, 2009
Record Details
This FDA Inspection record concerns Fayez E. Shamoon, M.D., with an inspection on March 20, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fayez E. Shamoon, M.D.
- Inspection Date
- March 20, 2009
- Product Type
- Devices
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ID · 9d4f7635-b20a-4be5-af66-a9d1404dc547
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 572750
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
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