FDA WARNING_LETTER - Biomerieux Inc - July 30, 2014

FDA WARNING_LETTER for Biomerieux Inc on July 30, 2014. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Biomerieux Inc on July 30, 2014. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.30(h)

21 CFR 820.100(a)

21 CFR 820

21 CFR 820.200(b)

21 CFR 820.72(a)

21 U.S.C. 321(h)

21 CFR 820.100(b)

21 CFR 820.90(a)

21 CFR 820.198(a)

21 U.S.C. 351(h)

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Record Information

Company

Biomerieux Inc

Inspection Date

July 30, 2014

Product Type

Devices

Office

Kansas City District Office

People

ID: 27d2d192-fad8-42d8-b27e-1fb9fbd493af

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