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Warning Letter

Case 698214 — FEI 1000120743

Facility

Recent inspections

  • 1290240 (OAI Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1240946 (OAI Tue Sep 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1035885 (NAI Thu Nov 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 850106 (NAI Thu Sep 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 724038 (NAI Tue May 10 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Hologic, Inc
Date
December 18, 2024
Fiscal Year
2025
Product Type
Devices
Center
CDRH
Location
Marlborough, MA (United States)