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1146276

Bloodworks — FEI 3071347

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 16, 2021
Fiscal Year
2021
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Seattle, WA (United States)

Facility

Other inspections at this facility

  • 1238690 (VAI Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1087821 (VAI Thu Apr 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056331 (NAI Thu Jun 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1052060 (NAI Fri May 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1027845 (NAI Fri Sep 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1238721 CFR 1271.220(a)Causing contamination, increasing risks
135821 CFR 211.100(b)SOPs not followed / documented
145021 CFR 211.113(a)Procedures for non-sterile drug products
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs