FDA WARNING_LETTER - Marck Biosciences Ltd. - November 01, 2013

FDA WARNING_LETTER for Marck Biosciences Ltd. on November 01, 2013. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Marck Biosciences Ltd. on November 01, 2013. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 211.56(a)

21 CFR 211

21 CFR 211.188(b)

21 CFR 210

21 CFR 211.125(a)

21 CFR 211.25(a)

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

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

21 CFR 211.142

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Record Information

Company

Marck Biosciences Ltd.

Inspection Date

November 1, 2013

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Thomas J. Cosgrove

ID: eaa654ed-0464-4f5d-ae53-fee6d26e70e5

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