FDA Inspection
James B DeVille, MDJames B DeVille, MD – FDA Inspection, Nov 4, 2016
Record Details
This FDA Inspection record concerns James B DeVille, MD, with an inspection on November 4, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992240
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 812.140(a)(3)(ii)Investigator records of relevant observations inadequate
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