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Roen Health, Inc. dba RoenRx Warning Letter Details

Warning Letter

Roen Health, Inc. dba RoenRx

Recipient Title Founder & Chief Executive Officer, Roen Health, Inc. dba RoenRx, 30 Irving Pl New York , NY 10003 United States

Issue DateJune 08, 2026

FEI NumberN/A

Violations1

CountryUnited States

Issuing Office

Center for Drug Evaluation and Research (CDER)

Product Type

Drugs

Status

Open

Subject

False & Misleading Claims/Misbranded (Telehealth)

Roen Health, Inc. dba RoenRx FDA Warning Letter, June 8, 2026