Warning Letters
Learn about the types of warning letters on FDA's website.
- Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
- To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.
- Frequently requested records may be accessed on the Reading Room page.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Maximus Health, Inc. dba Maximus | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
… Research (CDER) … False & Misleading Claims/Misbranded (Telehealth) … 3032037948 … Drugs … | ||||
| Trinity HealthCare Supply, LLC dba altRx | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
… Research (CDER) … False & Misleading Claims/Misbranded (Telehealth) … 3044175714 … Drugs … | ||||
| Glow Medispa, LLC dba Mint Med | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
… Research (CDER) … False & Misleading Claims/Misbranded (Telehealth) … 3044896930 … Drugs … | ||||
| Ezra Holdco LLC dba Ezra | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … Research (CDER) … False & Misleading Claims/Misbranded (Telehealth) … 3045074898 … Drugs … | ||||
| Public Health Solution LLC dba DrMedHealth | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … Research (CDER) … False & Misleading Claims/Misbranded (Telehealth) … 3044020737 … Drugs … | ||||
| D&H Medical Services | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … Research (CDER) … False & Misleading Claims/Misbranded (Telehealth) … 3044174854 … Drugs … | ||||
| Amie Health, Inc. dba Amie | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … Research (CDER) … False & Misleading Claims/Misbranded (Telehealth) … 3044000672 … Drugs … | ||||
| Altru Telehealth, LLC dba Altru Telehealth | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … Altru Telehealth, LLC dba Altru Telehealth … June 8, 2026 WARNING LETTER Reference number: MARCS-CMS 728274 To Altru Telehealth: This warning letter advises you of significant … | ||||
| Eden Health International Inc. dba Eden | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … Research (CDER) … False & Misleading Claims/Misbranded (Telehealth) … 3044020039 … Drugs … | ||||
| NativeMed LLC dba NativeMed | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … Research (CDER) … False & Misleading Claims/Misbranded (Telehealth) … 3044024130 … Drugs … |