1147132
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 26, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Christiansburg, VA (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7270 | 21 CFR 56.103(a) | IRB review requirement |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7518 | 21 CFR 312.64(d) | Financial info |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7632 | 21 CFR 312.6(a) | Required label statement |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |
| 7695 | 21 CFR 50.25(c) | ClincialTrials.gov statement |