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Warning Letter

Case 532743 — FEI 1218996

Facility

Recent inspections

  • 1280392 (OAI Tue Aug 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1144696 (VAI Tue Jun 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107302 (VAI Mon Oct 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016218 (OAI Thu Jun 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 884803 (NAI Wed Jun 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Other compliance actions

Action Details

Facility
Magellan Diagnostics, Inc.
Date
October 23, 2017
Fiscal Year
2018
Product Type
Devices
Center
CDRH
Location
North Billerica, MA (United States)