FDA WARNING_LETTER - Apotex Inc. - August 14, 2009

FDA WARNING_LETTER for Apotex Inc. on August 14, 2009. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Apotex Inc. on August 14, 2009. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 801(a)(3)

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

21 CFR 314.81(b)(1)

21 CFR 211

21 U.S.C. 355(k)

21 CFR 210

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

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Record Information

Company

Apotex Inc.

Inspection Date

August 14, 2009

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 5acd2173-ded4-4ed5-8b95-e010aaf11dc9

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