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986276

Abbott Laboratories — FEI 2919069

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 10, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Santa Clara, CA (United States)

Facility

Other inspections at this facility

  • 1017182 (NAI Wed May 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 834101 (NAI Thu May 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 716720 (NAI Fri Apr 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 605426 (NAI Wed Aug 12 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
319221 CFR 820.30(g)Design validation - user needs and intended uses
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
73221 CFR 803.50(a)(2)Individual Report of Malfunction