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1209394

Abbott Medical — FEI 2017865

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 28, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Sylmar, CA (United States)

Facility

Other inspections at this facility

  • 1120476 (NAI Fri Jan 17 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099418 (VAI Fri Aug 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1000696 (VAI Fri Feb 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 964165 (NAI Thu Mar 24 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 952517 (NAI Tue Nov 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
419121 CFR 806.10(a)(1)Report of risk to health