FDA Inspection
Edwin C. McGee, Jr., MDEdwin C. McGee, Jr., MD – FDA Inspection, Apr 25, 2011
Record Details
This FDA Inspection record concerns Edwin C. McGee, Jr., MD, with an inspection on April 25, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Edwin C. McGee, Jr., MD
- Inspection Date
- April 25, 2011
- Product Type
- Devices
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ID · 30cad174-ac7c-459c-bf70-7a75e618c751
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 720169
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(4)Investigator protocol records inadequate
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.140(a)(3)(ii)Investigator records of relevant observations inadequate
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
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Other FDA inspections of Edwin C. McGee, Jr., MD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2018 | Not classified | Chicago District Office | Project Evaluation: Devices |
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