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851694

Welch Allyn Inc (Baxter affiliate) — FEI 2183461

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 18, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Milwaukee, WI (United States)

Facility

Other inspections at this facility

  • 1174547 (VAI Fri Jul 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015603 (VAI Fri Apr 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 723748 (VAI Tue May 10 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1471721 CFR 820.30(g)Design validation - software validation documentation