FDA WARNING_LETTER - Analyticon Biotechnologies AG - March 29, 2012

FDA WARNING_LETTER for Analyticon Biotechnologies AG on March 29, 2012. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Analyticon Biotechnologies AG on March 29, 2012. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

21 U.S.C. 351(f)(1)(B)

21 CFR 820

21 CFR 820.72(a)

21 U.S.C. 321(h)

21 CFR 820.100(a)(1)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

21 CFR 807.81(b)

21 U.S.C. 351(h)

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Record Information

Company

Analyticon Biotechnologies AG

Inspection Date

March 29, 2012

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Alberto Gutierrez (Director)

ID: 1f32460e-91e7-4203-a114-bc310645e426

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