FDA Inspection 905708 — Kaiser Permanente-Sunnyside Medical Center
The FDA completed an inspection of Kaiser Permanente-Sunnyside Medical Center on December 4, 2014 in Clackamas, OR. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 4, 2014
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Clackamas, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |