1095769
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 8, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Ann Arbor, MI (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7387 | 21 CFR 50.25(a)(1) | Statement of research, purpose, duration of participation |
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7488 | 21 CFR 312.59 | Records of unused drug disposition |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7552 | 21 CFR 312.66 | Changes in research |