FDA Inspection 1021780 — CARE for the Bay Area

CARE for the Bay Area — FEI 3009473818

The FDA completed an inspection of CARE for the Bay Area on August 16, 2017 in Los Gatos, CA. 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: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 16, 2017
Fiscal Year
2017
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Los Gatos, CA (United States)

Citations

IDCFRDescription
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence