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1015603

Welch Allyn Inc (Baxter affiliate) — FEI 2183461

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 7, 2017
Fiscal Year
2017
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))
  • 851694 (VAI Wed Sep 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 723748 (VAI Tue May 10 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
311721 CFR 820.70(i)Software validation for automated processes
312721 CFR 820.80(e)Documentation
313021 CFR 820.100(a)Lack of or inadequate procedures
316821 CFR 820.198(a)Complaints
317221 CFR 820.198(c)Investigation of device failures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures