FDA WARNING_LETTER - Hims & Hers Health, Inc. dba Hers - August 01, 2025

FDA WARNING_LETTER for Hims & Hers Health, Inc. dba Hers on August 01, 2025. Product: drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Hims & Hers Health, Inc. dba Hers on August 01, 2025. Product: drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(c)

FD&C Act 301(c)

21 U.S.C. 321(p)

21 U.S.C. 352(a)

FD&C Act 301(a)

FD&C Act 201(p)

FD&C Act 502(bb)

21 U.S.C. 352(bb)

FD&C Act 201(g)(1)

FD&C Act 502(a)

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Record Information

Company

Hims & Hers Health, Inc. dba Hers

Inspection Date

August 1, 2025

Product Type

drugs

Office

Center for Drug Evaluation and Research

People

ID: 9b9ee03a-d445-4041-91f6-30ffb7f96fa0

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