Home / Compliance actions / 663150

Warning Letter

Case 663150 — FEI 1220648

Facility

Recent inspections

  • 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))

Other compliance actions

Action Details

Facility
Abiomed, Inc.
Date
September 19, 2023
Fiscal Year
2023
Product Type
Devices
Center
CDRH
Location
Danvers, MA (United States)