FDA Inspection
Stevan Himmelstein, MDStevan Himmelstein, MD – FDA Inspection, Jan 23, 2013
Record Details
This FDA Inspection record concerns Stevan Himmelstein, MD, with an inspection on January 23, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Stevan Himmelstein, MD
- Inspection Date
- January 23, 2013
- Product Type
- Devices
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ID · bfefa253-5125-4e18-92c0-723e22869bd7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 816968
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(4)Investigator protocol records inadequate
- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
- 21 CFR 812.140(a)(5)Additional investigator records FDA requires
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