FDA WARNING_LETTER - Jubilant Generics Limited - August 08, 2018

FDA WARNING_LETTER for Jubilant Generics Limited on August 08, 2018. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Jubilant Generics Limited on August 08, 2018. 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 210

21 CFR 211.110(c)

21 CFR 211.192

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

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

21 CFR 211.34

21 U.S.C. 356C(b)

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Record Information

Company

Jubilant Generics Limited

Inspection Date

August 8, 2018

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 78b01487-1252-4946-a390-b1bd324069c9

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