FDA Inspection 637838 — Daniel H. Present, M.d.
The FDA completed an inspection of Daniel H. Present, M.d. on January 13, 2010 in New York, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 13, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- New York, NY (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7562 | 21 CFR 312.60 | Informed consent |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |