FDA Inspection 1110470 — Western Reserve Health Education IRB
The FDA completed an inspection of Western Reserve Health Education IRB on November 20, 2019 in Youngstown, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 20, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Youngstown, OH (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |