FDA Inspection 1055154 — Sudhir Gupta, M.D., Ph.D., M.A.C.P
The FDA completed an inspection of Sudhir Gupta, M.D., Ph.D., M.A.C.P on Jun 11, 2018 in Irvine, 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
- Jun 11, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Irvine, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |