FDA WARNING_LETTER - Korea United Pharm - March 04, 2015

FDA WARNING_LETTER for Korea United Pharm on March 04, 2015. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Korea United Pharm on March 04, 2015. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 379j-41

21 U.S.C. 379j-42

21 U.S.C. 352(aa)

21 U.S.C. 379j-42(g)(4)(A)(iii)

21 U.S.C. 332

21 U.S.C. 334

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

21 U.S.C. 355(j)(5)(A)

21 U.S.C. 331(a)

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Record Information

Company

Korea United Pharm

Inspection Date

March 4, 2015

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Michael M. Levy

ID: eea6a8f7-9559-4c50-be9e-52e441853794

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