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 |
|---|---|---|---|---|---|---|---|
| NativeMed LLC dba NativeMed | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, … website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) … or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. … | ||||
| HydraMed IV LLC dba HydraMed | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, … website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) … or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. … | ||||
| Nexus Health Solutions LLC dba Harper Meds | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, … website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) … or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. … | ||||
| FitRX, LLC dba AM RX | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, … website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) … or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. … | ||||
| Altru Telehealth, LLC dba Altru Telehealth | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, … website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) … or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. … | ||||
| Eden Health International Inc. dba Eden | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, … website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) … or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. … | ||||
| Trinity HealthCare Supply, LLC dba altRx | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
… your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, … website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) … or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. … | ||||
| Amie Health, Inc. dba Amie | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, … website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) … or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. … | ||||
| Thrivelab Co. dba Thrivelab | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
… your website offers compounded drug products, including semaglutide products. 1 As described below, your website’s false or misleading claims concerning compounded semaglutide products under sections 502(a) and 502(bb) of the … or operations. Your representations regarding compounded semaglutide products are false or misleading. Under section … | ||||
| VivioMD Group LLC dba VivioMD | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, … website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) … or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. … |