FDA Inspection
Aradhana M. Venkatesan, MD, Clinical InvestigatorAradhana M. Venkatesan, MD, Clinical Investigator – FDA Inspection, Dec 13, 2011
Record Details
This FDA Inspection record concerns Aradhana M. Venkatesan, MD, Clinical Investigator, with an inspection on December 13, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 13, 2011
- Product Type
- Devices
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ID · 9ebe1630-6e10-4d1a-9f6f-c97b960cf8c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 756355
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.150(a)(4)No approval for investigator change in non-emergency
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