FDA Inspection 699003 — Manoj K. Patel
The FDA completed an inspection of Manoj K. Patel on November 23, 2010 in Riverside, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 23, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Riverside, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2984 | 21 CFR 812.140(a)(3)(i) | Investigator records of informed consent inadequate |
| 7543 | 21 CFR 312.61 | Unauthorized recipients (investigator) |
| 7552 | 21 CFR 312.66 | Changes in research |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |