FDA WARNING_LETTER - Lupin Limited - December 04, 2018

FDA WARNING_LETTER for Lupin Limited on December 04, 2018. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Lupin Limited on December 04, 2018. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

FD&C Act 801(a)(3)

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

Lupin Limited

Inspection Date

December 4, 2018

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 01ac99aa-9d61-44dd-82c6-28236dd0cc20

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