FDA Inspection 756640 — Bloodworks

Bloodworks — FEI 3006417870

The FDA completed an inspection of Bloodworks on December 6, 2011 in Federal Way, 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
December 6, 2011
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Federal Way, WA (United States)

Citations

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