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1290240

Hologic, Inc — FEI 1000120743

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 4, 2025
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Marlborough, MA (United States)

Facility

Other inspections at this facility

  • 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))
  • 712158 (NAI Wed Feb 23 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures