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1270474

Clarus Medical, Llc — FEI 1000116142

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 22, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Minneapolis, MN (United States)

Facility

Other inspections at this facility

  • 1137113 (NAI Wed Mar 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063426 (NAI Thu Aug 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 922562 (NAI Mon Apr 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 735517 (NAI Mon Jul 25 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate