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1234317

Abiomed, Inc. — FEI 1220648

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 5, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Danvers, MA (United States)

Facility

Other inspections at this facility

  • 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))
  • 899479 (NAI Thu Oct 09 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
419121 CFR 806.10(a)(1)Report of risk to health
45421 CFR 820.40(a)Document review, approval by designated individual
73121 CFR 803.50(a)(1)Report of Death or Serious Injury