FDA WARNING_LETTER - Prodrome Sciences USA, LLC - January 10, 2025

FDA WARNING_LETTER for Prodrome Sciences USA, LLC on January 10, 2025. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Prodrome Sciences USA, LLC on January 10, 2025. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 312.40(a)

21 CFR 312.20(a)

21 U.S.C. 355

21 CFR 312.20(b)

FD&C Act 201(g)(1)

21 CFR 312.20

21 CFR 312.40

FD&C Act 505

21 CFR 312.2

21 CFR 312

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Record Information

Company

Prodrome Sciences USA, LLC

Inspection Date

January 10, 2025

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 5dbe5e22-942b-482b-a753-c84dfa82e0b2

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