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1198214

Veran Medical Technologies Inc — FEI 3007222345

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 23, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Saint Louis, MO (United States)

Facility

Other inspections at this facility

  • 1147930 (VAI Thu Jul 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1077815 (VAI Thu Jan 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042301 (VAI Fri Feb 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 912700 (NAI Wed Feb 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 677305 (NAI Wed Aug 25 2010 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
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation
73121 CFR 803.50(a)(1)Report of Death or Serious Injury