FDA WARNING_LETTER - Denison Pharmaceuticals, LLC - February 09, 2023

FDA WARNING_LETTER for Denison Pharmaceuticals, LLC on February 09, 2023. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Denison Pharmaceuticals, LLC on February 09, 2023. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

FD&C Act 301(d)

21 U.S.C. 321(p)

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

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

21 CFR 211

FD&C Act 201(p)

21 U.S.C. 331

FD&C Act 201(g)(1)

FD&C Act 301

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Record Information

Company

Denison Pharmaceuticals, LLC

Inspection Date

February 9, 2023

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

ID: c2965870-94dc-43e6-b329-b059c7876903

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