FDA Inspection 1021088 — Kaiser Foundation Research Institute IRB #8
The FDA completed an inspection of Kaiser Foundation Research Institute IRB #8 on August 10, 2017 in Oakland, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 10, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Oakland, CA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7276 | 21 CFR 56.107(c) | One scientific and one non-scientific member |
| 7290 | 21 CFR 56.108(c) | Members present for review |