FDA WARNING_LETTER - Hydroxie, LLC - May 31, 2025

FDA WARNING_LETTER for Hydroxie, LLC on May 31, 2025. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Hydroxie, LLC on May 31, 2025. 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. 348(a)

21 U.S.C. 321(p)

FD&C Act 409(a)

21 U.S.C. 331(a)

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

21 U.S.C. 342(a)(2)(C)(i)

FD&C Act 201(s)

FD&C Act 505(a)

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Record Information

Company

Hydroxie, LLC

Inspection Date

May 31, 2025

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 5ffa78c1-fbeb-4a60-9bbc-8783cd68b882

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