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1207688

ICU Medical Inc — FEI 2183161

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 9, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Saint Paul, MN (United States)

Facility

Other inspections at this facility

  • 1252032 (NAI Tue Oct 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083812 (NAI Wed Feb 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1047692 (NAI Wed Apr 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures