FDA Inspection 854225 — Heartland Regional Med Center IRB
The FDA completed an inspection of Heartland Regional Med Center IRB on Nov 7, 2013 in Saint Joseph, MO. 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
- Nov 7, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Saint Joseph, MO (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |