FDA WARNING_LETTER - Aztex Enterprises Ltd. - June 13, 2017

FDA WARNING_LETTER for Aztex Enterprises Ltd. on June 13, 2017. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Aztex Enterprises Ltd. on June 13, 2017. 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 210

21 CFR 211.22(a)

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

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

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Record Information

Company

Aztex Enterprises Ltd.

Inspection Date

June 13, 2017

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Thomas J. Cosgrove

ID: 2df3e01a-b69a-457e-893d-0dfc2e87686b

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