FDA Inspection
Jack Barkin, MDJack Barkin, MD – FDA Inspection, Jan 19, 2012
Record Details
This FDA Inspection record concerns Jack Barkin, MD, with an inspection on January 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Jack Barkin, MD
- Inspection Date
- January 19, 2012
- Product Type
- Devices
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ID · e1aadb01-0fc8-4a4e-9b2c-56ae400ce425
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 765877
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 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)(ii)Investigator records of relevant observations inadequate
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
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