FDA Inspection
James C. Roberts, M.D.James C. Roberts, M.D. – FDA Inspection, Apr 7, 2017
Record Details
This FDA Inspection record concerns James C. Roberts, M.D., with an inspection on April 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3a406e9c-bcf2-47d7-9716-5557d6fb40d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010158
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 812.2(b)Abbreviated requirements / non-significant risk study
- 21 CFR 50.25(a)(3)Benefits to the subject
- 21 CFR 50.25(a)(1)Statement of research, purpose, duration of participation
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
- 21 CFR 50.25(a)(4)Alternate procedures, courses of treatment
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