FDA WARNING_LETTER - IDT Australia Ltd. - December 08, 2017

FDA WARNING_LETTER for IDT Australia Ltd. on December 08, 2017. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for IDT Australia Ltd. on December 08, 2017. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 801(a)(3)

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

21 CFR 211.160(b)

21 CFR 211

21 CFR 210

21 CFR 211.22(a)

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

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

21 CFR 211.194(a)

21 U.S.C. 356C(b)

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Record Information

Company

IDT Australia Ltd.

Inspection Date

December 8, 2017

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: eb5a0988-d6ee-4e47-a3eb-dfde73b1c43c

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