FDA Inspection 756355 — Aradhana M. Venkatesan, MD, Clinical Investigator
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
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 3028 | 21 CFR 812.150(a)(4) | No approval for investigator change in non-emergency |