FDA WARNING_LETTER - Sun Pharmaceutical Industries Ltd. - September 19, 2014

FDA WARNING_LETTER for Sun Pharmaceutical Industries Ltd. on September 19, 2014. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sun Pharmaceutical Industries Ltd. on September 19, 2014. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

21 CFR 211.42(c)(10)(i)

FD&C Act 801(a)(3)

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

21 CFR 211.68(a)

21 CFR 211.42(c)(10)(iv)

21 CFR 211

21 CFR 211.68(b)

21 CFR 210

21 CFR 211.192

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Record Information

Company

Sun Pharmaceutical Industries Ltd.

Inspection Date

September 19, 2014

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Thomas J. Cosgrove

ID: c47c7a2a-bcf4-4058-886e-9955a504f687

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