FDA WARNING_LETTER - FormPour - December 01, 2025

FDA WARNING_LETTER for FormPour on December 01, 2025. Product: drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for FormPour on December 01, 2025. Product: drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 321(p)

21 U.S.C. 331(dd)

FD&C Act 201(p)

21 U.S.C. 355

FD&C Act 201(g)(1)

21 CFR 201.128

FD&C Act 301(d) of the FD&C Act

FD&C Act 505

FD&C Act 505(a)

21 U.S.C. 355(a)

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Record Information

Company

FormPour

Inspection Date

December 1, 2025

Product Type

drugs

Office

Office of Unapproved Drugs & Labeling Compliance

People

ID: 554d9b4a-b0c5-4320-bd9e-cd245f5fba26

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