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564161

Boston Scientific Corp. — FEI 1000121056

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 12, 2009
Fiscal Year
2009
Product Type
Devices
Project Area
Compliance: Devices
Location
Coventry, RI (United States)

Facility

Other inspections at this facility

  • 1066822 (NAI Thu Sep 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 924170 (VAI Tue Mar 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 825230 (NAI Mon Mar 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 709045 (VAI Fri Jan 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 614007 (NAI Thu Sep 24 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
230221 CFR 820.20(e)Quality System Procedures
311721 CFR 820.70(i)Software validation for automated processes
313021 CFR 820.100(a)Lack of or inadequate procedures
327121 CFR 820.80(d)Quarantine of finished devices
369621 CFR 820.100(b)Documentation