FDA Inspection
Huber, Bryan M., M.D.Huber, Bryan M., M.D. – FDA Inspection, Dec 8, 2014
Record Details
This FDA Inspection record concerns Huber, Bryan M., M.D., with an inspection on December 8, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Huber, Bryan M., M.D.
- Inspection Date
- December 8, 2014
- Product Type
- Devices
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ID · 6a8aa21e-1cda-49df-a68f-1977261f151b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 906607
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
9- 21 CFR 812.110(b)Investigator 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 adverse effect records inadequate
- 21 CFR 812.140(a)(1)Investigator correspondence records inadequate
- 21 CFR 812.140(d)Record retention inadequate
- 21 CFR 812.110(a)Subject participation prior to study approval
- 21 CFR 50.20Circumstances of obtaining consent
- 21 CFR 812.100No investigator protection - subject rights, safety, welfare
- 21 CFR 812.110(d)Inadequate financial disclosure by investigator
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