FDA WARNING_LETTER - Aurobindo Pharma Limited - February 09, 2019

FDA WARNING_LETTER for Aurobindo Pharma Limited on February 09, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Aurobindo Pharma Limited on February 09, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 501(a)(2)(B)

21 CFR 314.70(c)(6)(i)

21 CFR 314.97(a)

21 CFR 314.420

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

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

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Record Information

Company

Aurobindo Pharma Limited

Inspection Date

February 9, 2019

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Francis Godwin (Director)

ID: d3443fe6-06c1-4cca-9cf2-4e6642d8b4ef

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