FDA WARNING_LETTER - Apotex Research Private Limited - July 01, 2014

FDA WARNING_LETTER for Apotex Research Private Limited on July 01, 2014. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Apotex Research Private Limited on July 01, 2014. 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 211

21 CFR 211.68(b)

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

21 CFR 210

21 CFR 211.192

21 CFR 211.113(a)

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

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

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Record Information

Company

Apotex Research Private Limited

Inspection Date

July 1, 2014

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: c495a8cb-2d48-4dc3-87b9-48e3e60b41f8

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