FDA Inspection 605966 — Brian Berman MD
The FDA completed an inspection of Brian Berman MD on Aug 24, 2009 in Baltimore, MD. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 24, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Baltimore, MD (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7517 | 21 CFR 312.66 | Initial and continuing review |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7562 | 21 CFR 312.60 | Informed consent |