FDA WARNING_LETTER - FMKLABS - December 31, 2024

FDA WARNING_LETTER for FMKLABS on December 31, 2024. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for FMKLABS on December 31, 2024. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

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

21 CFR 211.160(b)

21 CFR 211

21 CFR 210

21 CFR 211.192

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

21 CFR 211.34

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Record Information

Company

FMKLABS

Inspection Date

December 31, 2024

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Francis Godwin (Director)

ID: a22c49f9-c623-482e-9843-06ca7bbed53f

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