FDA WARNING_LETTER - Glenmark Pharmaceuticals Ltd - February 14, 2025

FDA WARNING_LETTER for Glenmark Pharmaceuticals Ltd on February 14, 2025. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Glenmark Pharmaceuticals Ltd on February 14, 2025. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.166(a)

21 CFR 211.160(b)

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

Glenmark Pharmaceuticals Ltd

Inspection Date

February 14, 2025

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Francis Godwin (Director)

ID: f05498db-6645-42ab-81ff-8a03eb201f2f

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