FDA WARNING_LETTER - Akorn, Inc. - May 16, 2018

FDA WARNING_LETTER for Akorn, Inc. on May 16, 2018. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Akorn, Inc. on May 16, 2018. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

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

21 CFR 211.42(c)(10)

21 CFR 211.166(a)

21 CFR 211

21 CFR 210

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

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

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Record Information

Company

Akorn, Inc.

Inspection Date

May 16, 2018

Product Type

Drugs

Office

Detroit District Office

People

ID: d07fe095-26cd-49a4-a448-3b6512830353

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