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1246067

Boston Scientific Corporation — FEI 3005099803

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 26, 2024
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Marlborough, MA (United States)

Facility

Other inspections at this facility

  • 1072267 (NAI Wed Oct 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1068733 (VAI Thu Sep 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 977724 (NAI Tue Jul 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 853358 (NAI Thu Oct 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 790237 (VAI Tue Jul 10 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
73221 CFR 803.50(a)(2)Individual Report of Malfunction