FDA UNTITLED_LETTER - Wickliffe Pharmaceutical Inc - September 07, 2023

FDA UNTITLED_LETTER for Wickliffe Pharmaceutical Inc on September 07, 2023. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA UNTITLED_LETTER for Wickliffe Pharmaceutical Inc on September 07, 2023. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 CFR 211.113(b)

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

FD&C Act 360b(a)(4)

21 U.S.C. 360b

21 CFR 211.67

21 CFR 211.165(a)

21 CFR 210

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

21 CFR 530

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Record Information

Company

Wickliffe Pharmaceutical Inc

Inspection Date

September 7, 2023

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

ID: 2a133e07-0650-4846-9910-fe6b849886c9

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