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1025569

Boston Scientific Limited — FEI 3002806565

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 31, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Galway (Ireland)

Additional Details

Postmarket Audit Inspections

Facility

Other inspections at this facility

  • 986155 (NAI Thu Sep 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878978 (NAI Thu Apr 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 827456 (NAI Thu Mar 21 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 702566 (NAI Thu Dec 16 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 637220 (NAI Thu Dec 10 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures