FDA WARNING_LETTER - Merck KGaA - July 01, 2011

FDA WARNING_LETTER for Merck KGaA on July 01, 2011. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Merck KGaA on July 01, 2011. 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 211.160(b)

21 CFR 211

21 CFR 210

21 CFR 600.14(c)

21 CFR 211.192

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

21 CFR 601.12

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Record Information

Company

Merck KGaA

Inspection Date

July 1, 2011

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Steven J. Lynn

ID: 0bf4f20e-9b74-45f5-b7e2-2824aac26aec

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