FDA Inspection 1063044 — Hennepin County Med Ctr (Minneapolis) IRB #1
The FDA completed an inspection of Hennepin County Med Ctr (Minneapolis) IRB #1 on Aug 23, 2018 in Minneapolis, MN. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 23, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Minneapolis, MN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7324 | 21 CFR 56.111(a)(4) | Informed consent sought |
| 7328 | 21 CFR 56.111(b) | Vulnerable subject safeguards |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |