FDA WARNING_LETTER - Aarti Drugs Limited - November 05, 2012

FDA WARNING_LETTER for Aarti Drugs Limited on November 05, 2012. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Aarti Drugs Limited on November 05, 2012. 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 U.S.C. 356C(a)(1)

21 CFR 210

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

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

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Record Information

Company

Aarti Drugs Limited

Inspection Date

November 5, 2012

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Michael D. Smedley

ID: bd135226-c8c3-4c94-91a0-7d485d047dcd

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