FDA Inspection 885852 — VA Northeast Ohio Healthcare System IRB
The FDA completed an inspection of VA Northeast Ohio Healthcare System IRB on July 10, 2014 in Cleveland, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 10, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Cleveland, OH (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |