FDA Inspection
Hakaim Albert G., MDHakaim Albert G., MD – FDA Inspection, Nov 24, 2008
Record Details
This FDA Inspection record concerns Hakaim Albert G., MD, with an inspection on November 24, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hakaim Albert G., MD
- Inspection Date
- November 24, 2008
- Product Type
- Devices
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ID · 93f1ce27-9f81-4a99-a1ed-a6948dad8a1b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 547942
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 812.140(a)(4)Investigator protocol records inadequate
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
- 21 CFR 812.150(b)(1)Sponsor evaluation rpt not timely, distributed
- 21 CFR 50.25(a)(1)Statement of research, purpose, duration of participation
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