FDA Inspection 1167236 — Creighton University IRB
The FDA completed an inspection of Creighton University IRB on Apr 7, 2022 in Omaha, NE. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 7, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Omaha, NE (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7337 | 21 CFR 56.115(b) | Retention of records |