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1181513

Hologic, Inc. — FEI 2024800

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 14, 2022
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
San Diego, CA (United States)

Facility

Other inspections at this facility

  • 1252605 (NAI Tue Aug 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1076849 (NAI Mon Dec 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 998474 (NAI Wed Dec 07 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 977288 (NAI Thu Jun 30 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 958896 (NAI Fri Jan 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
319121 CFR 820.30(g)Design validation - production units
337521 CFR 820.198(e)Records of complaint investigation
73121 CFR 803.50(a)(1)Report of Death or Serious Injury