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718978

Bloodworks — FEI 3020842

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 5, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Bellevue, WA (United States)

Facility

Other inspections at this facility

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  • 1089146 (VAI Fri May 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019353 (NAI Mon Jul 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 884146 (NAI Mon Jun 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 796827 (VAI Mon Aug 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
6721 CFR 606.65(e)Following manufacturer's instructions
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations