FDA Inspection 752667 — Nicola P. Klein, M.D.
The FDA completed an inspection of Nicola P. Klein, M.D. on Oct 13, 2011 in Oakland, CA. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 13, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Oakland, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7658 | 21 CFR 50.25(b)(2) | Termination by investigator |