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823230

ICU Medical, Inc. — FEI 1713468

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 19, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: 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))
  • 956414 (NAI Fri Dec 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 809344 (VAI Fri Nov 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
334721 CFR 820.200(c)Service reports/MDRs/complaints