FDA WARNING_LETTER - Care Diagnostica GmbH - December 13, 2012

FDA WARNING_LETTER for Care Diagnostica GmbH on December 13, 2012. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Care Diagnostica GmbH on December 13, 2012. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.250(b)

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 381(a)

21 CFR 820.40(b)

21 U.S.C. 351(h)

21 CFR 820.70(g)

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Record Information

Company

Care Diagnostica GmbH

Inspection Date

December 13, 2012

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Alberto Gutierrez (Director)

ID: cda7745a-d235-435f-9c5a-9db5aab7cb37

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