FDA Inspection 773108 — Bloodworks

Bloodworks — FEI 3019844

The FDA completed an inspection of Bloodworks on March 9, 2012 in Renton, WA. 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
March 9, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Renton, WA (United States)

Citations

IDCFRDescription
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs