FDA Inspection
Dr. David VlahovDr. David Vlahov – FDA Inspection, Oct 8, 2009
Record Details
This FDA Inspection record concerns Dr. David Vlahov, with an inspection on October 8, 2009, covering devices.
- Company
- Dr. David Vlahov
- Inspection Date
- October 8, 2009
- Product Type
- Devices
View Company Profile
ID · 61f966e8-c653-4bcb-85b0-f04f2aa59b27
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 614747
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 812.150(a)(6)Investigator final report
- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.150(a)(5)Investigator report for lack of informed consent
- 21 CFR 812.100Investigator lack of control of investigational devices
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
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