FDA Inspection 799757 — Children's Hosp Of WI Institutional Review Board
The FDA completed an inspection of Children's Hosp Of WI Institutional Review Board on Sep 4, 2012 in Milwaukee, WI. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 4, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Milwaukee, WI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |