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953620

The Brigham and Women's Hospital, Inc. — FEI 3012030543

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 10, 2015
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Boston, MA (United States)

Facility

Other inspections at this facility

  • 1203279 (NAI Tue Apr 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152063 (OAI Thu Sep 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100702 (OAI Thu Aug 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891621 (VAI Fri Aug 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
63021 CFR 803.17Lack of Written MDR Procedures
64021 CFR 803.18(a)Event files -- failure to establish and maintain
65621 CFR 803.30(a)(1)Report of Death Within 10 Days
65821 CFR 803.30(a)(2)Report of Serious Injury Within 10 Days