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1240946

Hologic, Inc — FEI 1000120743

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 24, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Marlborough, MA (United States)

Facility

Other inspections at this facility

  • 1290240 (OAI Tue Nov 04 2025 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
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310421 CFR 820.30(j)Design history file
313021 CFR 820.100(a)Lack of or inadequate procedures
419221 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
73221 CFR 803.50(a)(2)Individual Report of Malfunction