FDA WARNING_LETTER - Apotex Inc. - October 26, 2012

FDA WARNING_LETTER for Apotex Inc. on October 26, 2012. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Apotex Inc. on October 26, 2012. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

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

21 CFR 211

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

21 CFR 210

21 CFR 211.192

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

Apotex Inc.

Inspection Date

October 26, 2012

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: f5a6262b-3ba8-4a19-8a13-996736fefd13

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