FDA Inspection 1010448 — Asante Health System IRB dba Southern Oregon IRB
The FDA completed an inspection of Asante Health System IRB dba Southern Oregon IRB on May 5, 2017 in Medford, OR. 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
- May 5, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Medford, OR (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |