FDA Inspection 1021242 — UnityPoint Health Des Moines IRB
The FDA completed an inspection of UnityPoint Health Des Moines IRB on August 11, 2017 in Des Moines, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 11, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Des Moines, IA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |