FDA WARNING_LETTER - CRS Medical Diagnostics, Inc. - December 28, 2007

FDA WARNING_LETTER for CRS Medical Diagnostics, Inc. on December 28, 2007. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for CRS Medical Diagnostics, Inc. on December 28, 2007. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 820.30(a)

21 CFR 820.181(a)

21 CFR 820.50(a)(2)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.100(a)(1)

21 CFR 820.100(a)(4)

21 CFR 807.97

21 CFR 820.20(c)

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Record Information

Company

CRS Medical Diagnostics, Inc.

Inspection Date

December 28, 2007

Product Type

Devices

Office

Minneapolis District Office

People

Charles Becoat (Director W.)

ID: 14b21a60-d576-44f2-87c1-60cfd06a3b51

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