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1195233

Luminex Corporation — FEI 3002524000

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 13, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Austin, TX (United States)

Facility

Other inspections at this facility

  • 1117835 (OAI Fri Feb 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 768656 (NAI Wed Feb 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 561479 (NAI Mon Feb 09 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation
73221 CFR 803.50(a)(2)Individual Report of Malfunction