FDA WARNING_LETTER - Luminex Corporation - February 14, 2020

FDA WARNING_LETTER for Luminex Corporation on February 14, 2020. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Luminex Corporation on February 14, 2020. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.75(b)

21 U.S.C. 352(t)(2)

21 CFR 820.100(a)

21 CFR 820

21 CFR 820.200(a)

21 U.S.C. 321(h)

21 U.S.C. 360(i)

21 CFR 820.50

21 CFR 806.10

21 U.S.C. 351(h)

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Record Information

Company

Luminex Corporation

Inspection Date

February 14, 2020

Product Type

Devices

Office

Division of Medical Device and Radiological Health Operations East

People

ID: 02b42ede-af22-4ce1-ba03-0e0f48ac82d3

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