FDA Inspection 1258239 — Asante Health System IRB dba Southern Oregon IRB
The FDA completed an inspection of Asante Health System IRB dba Southern Oregon IRB on January 10, 2025 in Medford, OR. 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
- January 10, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Medford, OR (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |