FDA WARNING_LETTER - Explora Laboratories - August 07, 2014

FDA WARNING_LETTER for Explora Laboratories on August 07, 2014. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Explora Laboratories on August 07, 2014. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 379j-42

21 U.S.C. 334

21 U.S.C. 352(aa)

21 U.S.C. 379j-41(5)(A)(i)

21 U.S.C. 331(a)

21 U.S.C. 332

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

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

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

21 U.S.C. 379j-42(l)

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Record Information

Company

Explora Laboratories

Inspection Date

August 7, 2014

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Michael M. Levy

ID: 2826d49c-2af6-45bd-b75e-5fa628c9da65

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