FDA Inspection 806424 — Western Reserve Health Education IRB
The FDA completed an inspection of Western Reserve Health Education IRB on November 9, 2012 in Youngstown, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 9, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Youngstown, OH (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |