FDA WARNING_LETTER - AMKS TIME RELEASE LAB, LLC - July 12, 2013

FDA WARNING_LETTER for AMKS TIME RELEASE LAB, LLC on July 12, 2013. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for AMKS TIME RELEASE LAB, LLC on July 12, 2013. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 312.40(a)

21 CFR 312.50

21 U.S.C. 355(i)

21 CFR 312.20(a)

21 U.S.C. 321(g)

21 CFR 312.57(a)

21 U.S.C. 355

21 CFR 312.40

21 CFR 312.56(a)

21 CFR 312.2(a)

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Record Information

Company

AMKS TIME RELEASE LAB, LLC

Inspection Date

July 12, 2013

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Sean Y. Kassim (Deputy Office Director)

ID: ba894059-cf4d-4059-9832-b7e9358461a0

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