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956414

ICU Medical, Inc. — FEI 1713468

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 11, 2015
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Salt Lake City, UT (United States)

Facility

Other inspections at this facility

  • 1229208 (NAI Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1085121 (VAI Thu Apr 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981035 (NAI Tue Mar 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 823230 (VAI Tue Mar 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 809344 (VAI Fri Nov 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
312721 CFR 820.80(e)Documentation
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures