FDA Inspection 1109215 — SCL Health IRB
The FDA completed an inspection of SCL Health IRB on November 7, 2019 in Broomfield, CO. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 7, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Broomfield, CO (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |