1147975
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 5, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Houston, TX (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7378 | 21 CFR 50.27(a) | Copy of consent form not provided |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |