FDA Inspection 1106245 — Trinity Hospital IRB # 1
The FDA completed an inspection of Trinity Hospital IRB # 1 on October 11, 2019 in Minot, ND. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 11, 2019
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Minot, ND (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7406 | 21 CFR 56.109(a) | Scope of reviews |