FDA WARNING_LETTER - Sanofi Aventis Deutschland GmbH - September 16, 2010

FDA WARNING_LETTER for Sanofi Aventis Deutschland GmbH on September 16, 2010. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sanofi Aventis Deutschland GmbH on September 16, 2010. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

FD&C Act 801(a)(3)

FD&C Act 501(a)(2)(B)

21 CFR 211

21 CFR 211.42(c)

21 CFR 210

21 CFR 211.25(a)

21 U.S.C. 381(a)(3)

21 U.S.C. 351(a)(2)(B)

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Record Information

Company

Sanofi Aventis Deutschland GmbH

Inspection Date

September 16, 2010

Product Type

Drugs

Office

Department of Health and Human Services

People

Richard L. Friedman (Director)

ID: 4d2d07d6-5a1b-4f1d-b0ea-934743054628

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