FDA WARNING_LETTER - GPT Pharmaceuticals Private Ltd - June 28, 2019

FDA WARNING_LETTER for GPT Pharmaceuticals Private Ltd on June 28, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for GPT Pharmaceuticals Private Ltd on June 28, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 801(a)(3)

21 CFR 211

21 CFR 211.67(a)

21 CFR 211.68(b)

21 CFR 210

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

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

21 CFR 211.22

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Record Information

Company

GPT Pharmaceuticals Private Ltd

Inspection Date

June 28, 2019

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Francis Godwin (Director)

ID: fc35dc3f-5ad2-4f98-831a-28c7cc7d1224

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