FDA Inspection 705762 — Freeman- Oak Hill Health System IRB #1
The FDA completed an inspection of Freeman- Oak Hill Health System IRB #1 on January 11, 2011 in Joplin, MO. 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
- January 11, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Joplin, MO (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7368 | 21 CFR 56.108(a)(2) | More frequent reviews, verification of no changes |