FDA WARNING_LETTER - Wockhardt Limited - July 31, 2013

FDA WARNING_LETTER for Wockhardt Limited on July 31, 2013. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Wockhardt Limited on July 31, 2013. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.166(a)

21 CFR 211.100(b)

21 CFR 211

21 CFR 211.68(b)

21 CFR 210

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

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

21 CFR 211.194(a)

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Record Information

Company

Wockhardt Limited

Inspection Date

July 31, 2013

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Steven J. Lynn

ID: b77a0aab-2daf-4055-b4e7-a6123716d3f4

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