FDA Inspection
Martin, Michael MDMartin, Michael MD – FDA Inspection, Dec 14, 2012
Record Details
This FDA Inspection record concerns Martin, Michael MD, with an inspection on December 14, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Martin, Michael MD
- Inspection Date
- December 14, 2012
- Product Type
- Devices
View Company Profile
ID · 5afa7103-d4ce-4f93-ad68-577b11179779
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 811729
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
- 21 CFR 812.140(a)(3)(ii)Investigator adverse effect records inadequate
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
- 21 CFR 812.140(a)(2)(iii)Investigator records of disposition of devices inadequate
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