FDA WARNING_LETTER - Kim Chemicals Private Ltd. - June 09, 2017

FDA WARNING_LETTER for Kim Chemicals Private Ltd. on June 09, 2017. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Kim Chemicals Private Ltd. on June 09, 2017. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 347

21 U.S.C. 331(d)

FD&C Act 301(d)

21 U.S.C. 321(p)

FD&C Act 801(a)(3)

21 CFR 341.74(d)(2)(ii)

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

21 CFR 341

21 CFR 341.20

21 CFR 341.40(u)

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Record Information

Company

Kim Chemicals Private Ltd.

Inspection Date

June 9, 2017

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Thomas J. Cosgrove

ID: cd76d933-1c7c-4c0f-bb3f-f18ca20664f1

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