FDA WARNING_LETTER - BluefitMD - December 31, 2025

FDA WARNING_LETTER for BluefitMD on December 31, 2025. Product: drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for BluefitMD on December 31, 2025. Product: drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 321(p)

21 U.S.C. 331(c)

FD&C Act 503A

FD&C Act 201(g)

21 CFR 201.61(a)

FD&C Act 503B(A)(10)(A)(i)

FD&C Act 301(c)

21 U.S.C. 352(a)

FD&C Act 503(b)

FD&C Act 201(p)

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Record Information

Company

BluefitMD

Inspection Date

December 31, 2025

Product Type

drugs

Office

Center for Drug Evaluation and Research

People

Matthew J. Lash (Acting Director)

ID: e75a0193-0850-4f45-a9ef-fa53d24e4065

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