FDA WARNING_LETTER - Sun Pharmaceutical Industries Limited - Karkhadi - November 16, 2013

FDA WARNING_LETTER for Sun Pharmaceutical Industries Limited - Karkhadi on November 16, 2013. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sun Pharmaceutical Industries Limited - Karkhadi on November 16, 2013. 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 CFR 210

21 CFR 211.25(a)

21 CFR 211.180(a)

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

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

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Record Information

Company

Sun Pharmaceutical Industries Limited - Karkhadi

Inspection Date

November 16, 2013

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 92b301af-c0b0-4b1e-8444-55defc1a85b4

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