FDA WARNING_LETTER - SANUM-Kehlbeck GmbH & Co. KG - March 26, 2013

FDA WARNING_LETTER for SANUM-Kehlbeck GmbH & Co. KG on March 26, 2013. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for SANUM-Kehlbeck GmbH & Co. KG on March 26, 2013. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.42(d)

21 U.S.C. 360(j)

21 CFR 211.113(b)

21 U.S.C. 360(i)(2)

21 CFR 211.110(a)

21 CFR 211

21 U.S.C. 360(i)(1)

21 U.S.C. 356C(a)(1)

21 CFR 210

21 CFR 211.28(a)

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Record Information

Company

SANUM-Kehlbeck GmbH & Co. KG

Inspection Date

March 26, 2013

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Steven J. Lynn

ID: dfc9db14-45f5-464c-a9be-f2eff43d2dee

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