FDA Inspection 863041 — MercyOne North Iowa Medical Center IRB
The FDA completed an inspection of MercyOne North Iowa Medical Center IRB on January 16, 2014 in Mason City, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 16, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Mason City, IA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7406 | 21 CFR 56.109(a) | Scope of reviews |