FDA Inspection 756355 — Aradhana M. Venkatesan, MD, Clinical Investigator

Aradhana M. Venkatesan, MD, Clinical Investigator — FEI 3009278268

The FDA completed an inspection of Aradhana M. Venkatesan, MD, Clinical Investigator on Dec 13, 2011 in Bethesda, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Dec 13, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Bethesda, MD (United States)

Additional Details

Clinical Investigator (CI)

Citations

IDCFRDescription
296821 CFR 812.100Investigator non-compliance with agreement/plan/regulations
302821 CFR 812.150(a)(4)No approval for investigator change in non-emergency