FDA WARNING_LETTER - GenoGenix, LLC - July 18, 2025

FDA WARNING_LETTER for GenoGenix, LLC on July 18, 2025. Product: drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for GenoGenix, LLC on July 18, 2025. Product: drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 U.S.C. 353b(d)(4)

21 U.S.C. 331(d)

21 CFR 211.113(b)

21 U.S.C. 353b(a)(1)

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

21 U.S.C. 353b(b)(5)

21 CFR 211.42(c)(10)

FD&C Act 501(c)

FD&C Act 503A

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Record Information

Company

GenoGenix, LLC

Inspection Date

July 18, 2025

Product Type

drugs

Office

Center for Drug Evaluation and Research

People

ID: b6368e01-b770-49ef-926c-511dd21cd06c

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