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1117864

Luminex Corporation — FEI 3006028115

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 14, 2020
Fiscal Year
2020
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Northbrook, IL (United States)

Facility

Other inspections at this facility

  • 1195245 (NAI Fri Jan 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155192 (VAI Fri Oct 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1005213 (NAI Fri Mar 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 958073 (NAI Wed Nov 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874256 (OAI Fri Apr 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
313021 CFR 820.100(a)Lack of or inadequate procedures
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation
421221 CFR 806.20(b)(4)Justification for not reporting