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982822

Foundation Medicine, Inc. — FEI 3010679023

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 22, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Cambridge, MA (United States)

Facility

Other inspections at this facility

  • 1177142 (NAI Thu Jul 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062851 (NAI Tue Jul 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042552 (VAI Wed Feb 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987340 (VAI Fri Sep 23 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
293021 CFR 812.42Sponsor began study before IRB/FDA approval
319221 CFR 820.30(g)Design validation - user needs and intended uses