FDA Inspection 1109631 — Mount Carmel Health System IRB
The FDA completed an inspection of Mount Carmel Health System IRB on October 29, 2019 in Columbus, OH. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 29, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Columbus, OH (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7305 | 21 CFR 56.110(b)(2) | Minor changes |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |