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1198362

Klarity Medical Products LLC — FEI 3001236129

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 16, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Heath, OH (United States)

Facility

Other inspections at this facility

  • 1148020 (VAI Fri Jul 09 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1119795 (OAI Tue Feb 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 991292 (VAI Tue Nov 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 850009 (VAI Mon Sep 30 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 648317 (VAI Tue Feb 23 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
333121 CFR 820.181DMR - not or inadequately maintained
54621 CFR 820.75(a)Lack of or inadequate process validation