FDA Inspection
Ralph Rashbaum, M.D.Ralph Rashbaum, M.D. – FDA Inspection, May 6, 2011
Record Details
This FDA Inspection record concerns Ralph Rashbaum, M.D., with an inspection on May 6, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ralph Rashbaum, M.D.
- Inspection Date
- May 6, 2011
- Product Type
- Devices
View Company Profile
ID · 6b37a3ca-e91f-4e19-af69-baa051d2e934
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 727483
- 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)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
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