FDA WARNING_LETTER - Mediagnost GmbH - January 11, 2012

FDA WARNING_LETTER for Mediagnost GmbH on January 11, 2012. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Mediagnost GmbH on January 11, 2012. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.120

21 CFR 820.80

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.70(a)

21 CFR 820.75(a)

21 CFR 820.60

21 U.S.C. 351(h)

21 CFR 820.40

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Record Information

Company

Mediagnost GmbH

Inspection Date

January 11, 2012

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Alberto Gutierrez (Director)

ID: b22e852a-d2ba-4139-970e-4babf0325b16

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