FDA WARNING_LETTER - GenLabMeds - August 01, 2025

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

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Record Summary

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

Violation Codes

FD&C Act 503A(b)(1)(A)(i)

21 U.S.C. 321(p)

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

21 U.S.C. 331(c)

21 U.S.C. 331(dd)

FD&C Act 503A

FD&C Act 506E

21 U.S.C. 331(a)

FD&C Act 301(c)

21 U.S.C. 353b(a)(2)(A)

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Record Information

Company

GenLabMeds

Inspection Date

August 1, 2025

Product Type

drugs

Office

Center for Drug Evaluation and Research

People

George Tidmarsh (Director)

ID: c34509ca-15e6-4841-8501-d66d7068a994

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