FDA Inspection
Jeff W. Elias, MDJeff W. Elias, MD – FDA Inspection, Jan 14, 2016
Record Details
This FDA Inspection record concerns Jeff W. Elias, MD, with an inspection on January 14, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Jeff W. Elias, MD
- Inspection Date
- January 14, 2016
- Product Type
- Devices
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ID · f56185bd-81a6-4106-99d3-35b3925cfa15
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 964814
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.140(a)(5)Additional investigator records FDA requires
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