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1243723

Xoran Technologies, LLC — FEI 3004198450

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 11, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Ann Arbor, MI (United States)

Facility

Other inspections at this facility

  • 1035619 (VAI Wed Dec 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 899086 (VAI Mon Oct 06 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 779682 (OAI Mon May 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 723737 (OAI Fri Apr 29 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 695219 (OAI Thu Oct 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
367721 CFR 820.30(g)Design validation - software validation not performed
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures