FDA Inspection
James Warner Genuario, MDJames Warner Genuario, MD – FDA Inspection, Dec 6, 2018
Record Details
This FDA Inspection record concerns James Warner Genuario, MD, with an inspection on December 6, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 737f0659-ed7c-4446-b660-4c9fc6ca0cf7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1073982
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 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 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)Investigator's subject records inadequate
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