FDA Inspection 885899 — Brian E. Driver, MD, Sponsor/Investigator
The FDA completed an inspection of Brian E. Driver, MD, Sponsor/Investigator on June 26, 2014 in Minneapolis, MN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 26, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Minneapolis, MN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7640 | 21 CFR 312.20(c) | IND for emergency research |