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932308

Welch Allyn, Inc. — FEI 1316463

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 10, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Skaneateles Falls, NY (United States)

Facility

Other inspections at this facility

  • 1298246 (VAI Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1215145 (NAI Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061645 (NAI Thu Jul 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 890794 (VAI Wed Aug 13 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 805650 (VAI Fri Oct 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
323121 CFR 820.70(i)Documentation of software validation
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures