Alkem Laboratories LtdSeptember 29, 2016

FDA 483 - Alkem Laboratories Ltd - September 29, 2016

FDA 483 for Alkem Laboratories Ltd on September 29, 2016. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA 483 for Alkem Laboratories Ltd on September 29, 2016. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 CFR 211.112

21 CFR 211.68(a)

21 CFR 211.166(a)

21 CFR 211.194(a)(2)

21 CFR 211.180(d)

21 CFR 211.22(a)

21 CFR 211.192

21 CFR 211.180(e)

21 CFR 211.142

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Record Information

Company

Alkem Laboratories Ltd

Inspection Date

September 29, 2016

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 61c75b26-5a21-4b13-85e8-2479ebceadb4

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