FDA WARNING_LETTER - lekapharma.com - September 10, 2020

FDA WARNING_LETTER for lekapharma.com on September 10, 2020. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for lekapharma.com on September 10, 2020. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 321(p)

21 U.S.C. 331(a)

21.U.S.C. 355(a)

21 U.S.C. 321(g)

21 U.S.C. 352(f)(1)

21 U.S.C. 353(b)

21 CFR 201.5

21 CFR 201.115

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Record Information

Company

lekapharma.com

Inspection Date

September 10, 2020

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Donald D. Ashley (Director)

ID: 5804662d-0dd0-4f62-8a3e-641b2d7b868e

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