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652658

Abiomed, Inc. — FEI 1220648

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 17, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Danvers, MA (United States)

Facility

Other inspections at this facility

  • 1234317 (OAI Tue Aug 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1202491 (OAI Thu Apr 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1131459 (NAI Tue Oct 06 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1021587 (NAI Thu Jul 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 964416 (NAI Fri Mar 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
336921 CFR 820.198(a)(1)Uniform and timely processing
419321 CFR 806.10(b)Time to report - 10 days
73121 CFR 803.50(a)(1)Report of Death or Serious Injury