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868462

Boston Scientific Corporation — FEI 1000116179

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 24, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Minnetonka, MN (United States)

Facility

Other inspections at this facility

  • 1036678 (NAI Mon Dec 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1018598 (NAI Tue Jun 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 958603 (VAI Fri Jan 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 828801 (NAI Thu Apr 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 818398 (VAI Fri Feb 15 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
54621 CFR 820.75(a)Lack of or inadequate process validation