FDA Inspection 1006029 — Ivy, David Dunbar M.D.
The FDA completed an inspection of Ivy, David Dunbar M.D. on Feb 23, 2017 in Aurora, CO. 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
- Feb 23, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Aurora, CO (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7364 | 21 CFR 50.55(g) | Documentation of assent of children |
| 7378 | 21 CFR 50.27(a) | Copy of consent form not provided |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |
| 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 |
| 7552 | 21 CFR 312.66 | Changes in research |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |