Home / Inspections / 826483

826483

Department of Veterans Affairs Medical Center — FEI 1972413

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 2, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Kansas City, MO (United States)

Facility

Other inspections at this facility

  • 1275732 (NAI Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1166527 (NAI Thu Mar 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1045892 (NAI Mon Mar 05 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 967419 (NAI Fri Apr 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 897317 (VAI Thu Sep 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
19821 CFR 640.2(c)(3)Blood not stored between 1-6 deg / shipped 1-10 deg
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9121 CFR 606.100(b)(12)Criteria for suitability of reissue of returned blood