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1049551

Abaxis Inc — FEI 2939693

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 25, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Union City, CA (United States)

Facility

Other inspections at this facility

  • 1100338 (VAI Thu Aug 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 894936 (NAI Wed Sep 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 775878 (NAI Tue Apr 03 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 703154 (VAI Wed Dec 22 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
53921 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.