FDA WARNING_LETTER - Bio-Rad Laboratories GmbH - January 22, 2015

FDA WARNING_LETTER for Bio-Rad Laboratories GmbH on January 22, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Bio-Rad Laboratories GmbH on January 22, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.20(c)

21 CFR 820.30(c)

21 CFR 820.30(f)

21 U.S.C. 351(h)

21 CFR 820.30(g)

21 CFR 820.30(e)

21 CFR 820.198(e)

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Record Information

Company

Bio-Rad Laboratories GmbH

Inspection Date

January 22, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 02e7d8bd-55a6-46d2-8d95-a27a2e583bd5

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