Home / Inspections / 1019474

1019474

Hologic, Inc. — FEI 1220984

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 28, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Radiation Control and Health Safety Act
Location
Danbury, CT (United States)

Facility

Other inspections at this facility

  • 1007334 (NAI Tue Apr 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878443 (VAI Fri Apr 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 785328 (NAI Fri Jun 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 701114 (VAI Wed Dec 15 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
500821 CFR 1002.20(a)Failure to report
501221 CFR 1003.10(a)FDA not notified of defect or noncompliance
544321 CFR 1020.30(g)Providing adequate assembly information
581121 CFR 1002.30(a)(1)Quality control procedures
581221 CFR 1002.30(a)(2)Results of tests