FDA Inspection 1237142 — WakeMed IRB
The FDA completed an inspection of WakeMed IRB on Apr 29, 2024 in Raleigh, NC. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 29, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Raleigh, NC (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 |
| 7334 | 21 CFR 56.115(a)(5) | List of members |