FDA Inspection 943095 — Sanjeev Puri, Clinical Investigator
The FDA completed an inspection of Sanjeev Puri, Clinical Investigator on Oct 1, 2015 in Moline, IL. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 1, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Moline, IL (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7517 | 21 CFR 312.66 | Initial and continuing review |
| 7520 | 21 CFR 312.64(b) | Safety reports |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7664 | 21 CFR 50.20 | Circumstances of obtaining consent |