FDA WARNING_LETTER - Sun Pharmaceutical Industries Ltd - May 09, 2022

FDA WARNING_LETTER for Sun Pharmaceutical Industries Ltd on May 09, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sun Pharmaceutical Industries Ltd on May 09, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

FD&C Act 801(a)(3)

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

21 CFR 211.42(c)(10)

21 CFR 211

21 CFR 211.67(a)

21 CFR 210

21 CFR 211.192

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 Ltd

Inspection Date

May 9, 2022

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 9abcf5f9-9c76-49e9-8d55-74a39ab4f121

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