FDA WARNING_LETTER - Indoco Remedies Limited - January 25, 2019

FDA WARNING_LETTER for Indoco Remedies Limited on January 25, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Indoco Remedies Limited on January 25, 2019. 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 211.188

21 CFR 210

21 CFR 211.192

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

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

21 CFR 211.34

21 CFR 211.194(a)

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Record Information

Company

Indoco Remedies Limited

Inspection Date

January 25, 2019

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Francis Godwin (Director)

ID: 36064184-0cc5-480f-bb1b-f0630c35a051

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