FDA Inspection 1272497 — Nebraska Methodist Hospital IRB
The FDA completed an inspection of Nebraska Methodist Hospital IRB on Jun 12, 2025 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 12, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Omaha, NE (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7692 | 21 CFR 56.106(e) | Changes in contact or chairperson information |