FDA WARNING_LETTER - Indoco Remedies Limited - July 26, 2024

FDA WARNING_LETTER for Indoco Remedies Limited on July 26, 2024. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Indoco Remedies Limited on July 26, 2024. 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

21 CFR 210

21 CFR 211.22(a)

21 CFR 211.192

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

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

21 CFR 211.160(a)

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Record Information

Company

Indoco Remedies Limited

Inspection Date

July 26, 2024

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Francis Godwin (Director)

ID: e38cf119-2868-489e-987f-8acda3d4a076

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