FDA Inspection
Vladimir Santos, MDVladimir Santos, MD – FDA Inspection, Dec 14, 2016
Record Details
This FDA Inspection record concerns Vladimir Santos, MD, with an inspection on December 14, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5de145e3-7bc9-469c-8dbc-00061fd105ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995373
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.140(a)(3)(ii)Investigator records of relevant observations inadequate
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