FDA Inspection 995641 — Kaiser Permanente-Sunnyside Medical Center

Kaiser Permanente-Sunnyside Medical Center — FEI 3076999

The FDA completed an inspection of Kaiser Permanente-Sunnyside Medical Center on November 2, 2016 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
November 2, 2016
Fiscal Year
2017
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Clackamas, OR (United States)

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
15521 CFR 606.160(b)Required records