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884835

Abbott Molecular, Inc. — FEI 3005248192

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 11, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Des Plaines, IL (United States)

Facility

Other inspections at this facility

  • 1195852 (VAI Fri Jan 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1136769 (NAI Fri Feb 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1098947 (NAI Wed Jul 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1068081 (NAI Thu Sep 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1013090 (NAI Thu May 04 2017 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
53721 CFR 820.70(a)Production processes