FDA Inspection 880280 — Emanuel Calenoff, M.D.
The FDA completed an inspection of Emanuel Calenoff, M.D. on May 22, 2014 in Dallas, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 22, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Dallas, TX (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |
| 7461 | 21 CFR 312.58(a) | FDA access to sponsor records |
| 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 |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |