FDA WARNING_LETTER - Diagnostics Biochem Canada, Inc. - September 09, 2011

FDA WARNING_LETTER for Diagnostics Biochem Canada, Inc. on September 09, 2011. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Diagnostics Biochem Canada, Inc. on September 09, 2011. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.250(a)

21 CFR 820.30(h)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.120(d)

21 CFR 820.80(a)

21 U.S.C. 351(h)

21 CFR 820.30(g)

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Record Information

Company

Diagnostics Biochem Canada, Inc.

Inspection Date

September 9, 2011

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Alberto Gutierrez (Director)

ID: 5b35237c-8eda-49ec-881f-2c244e53980b

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