Home / Inspections / 1204351

1204351

St Luke's Regional Medical Center — FEI 3071512

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 4, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Boise, ID (United States)

Facility

Other inspections at this facility

  • 1276932 (NAI Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028913 (NAI Fri Sep 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983622 (VAI Thu Aug 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 879345 (NAI Tue May 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 811102 (VAI Tue Dec 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
1803821 CFR 606.100(b)SOPs for investigations, records
922321 CFR 606.160(b)(6)Required records - transfusion reaction and complaints
9521 CFR 606.100(b)(16)Labeling procedures to avoid labeling mix-ups