FDA WARNING_LETTER - Par Health USA, LLC & Endo USA, Inc. - October 20, 2025

FDA WARNING_LETTER for Par Health USA, LLC & Endo USA, Inc. on October 20, 2025. Product: drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Par Health USA, LLC & Endo USA, Inc. on October 20, 2025. Product: drugs. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 211.42(c)(10)

21 CFR 211.160(b)

21 CFR 211

21 CFR 210

21 CFR 113(b)

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

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

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Record Information

Company

Par Health USA, LLC & Endo USA, Inc.

Inspection Date

October 20, 2025

Product Type

drugs

Office

Center for Drug Evaluation and Research

People

Francis Godwin (Director)

ID: 32bab0b6-24b8-48a6-bf9e-70147390f67b

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