FDA WARNING_LETTER - Evi Labs - January 15, 2025

FDA WARNING_LETTER for Evi Labs on January 15, 2025. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Evi Labs on January 15, 2025. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 CFR 211.160(b)

21 CFR 211

21 CFR 211.165(a)

21 CFR 210

21 CFR 211.22(a)

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

21 CFR 211.34

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Record Information

Company

Evi Labs

Inspection Date

January 15, 2025

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Francis Godwin (Director)

ID: cd3d6842-265a-402e-8578-1c371257da51

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