FDA Inspection 1081892 — Animesh Pardanani
The FDA completed an inspection of Animesh Pardanani on Mar 8, 2019 in Rochester, MN. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 8, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Rochester, MN (United States)
Additional details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7498 | 21 CFR 312.66 | Unanticipated problems |
| 7517 | 21 CFR 312.66 | Initial and continuing review |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |