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809757

Fresenius USA Manufacturing, Inc. — FEI 1713747

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 7, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Ogden, UT (United States)

Facility

Other inspections at this facility

  • 1142311 (VAI Fri May 21 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1126818 (VAI Thu Aug 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023304 (VAI Fri Aug 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015295 (NAI Thu May 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 861872 (VAI Fri Jan 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate