What FDA’s record states
| Field | What FDA’s record states | Source |
|---|---|---|
| Recipient | Tailstorm Health Inc. dba Medivant Health | FDA letter ↗ |
| Location | Phoenix, AZ | FDA letter ↗ |
| Letter date | Apr 8, 2025 | FDA letter ↗ |
| Posted by FDA | May 13, 2025 | FDA index ↗ |
| Issuing office | Center for Drug Evaluation and Research (CDER) | FDA letter ↗ |
| Subject | Compounding Pharmacy/Adulterated Drug Products | FDA letter ↗ |
| MARCS-CMS number | 703497 | FDA letter ↗ |
| GLP-1 drugs named | Semaglutide, Tirzepatide | FDA letter ↗ |
| Response letter | Not published by FDA | FDA letter ↗ |
| Closeout letter | Published 04/14/2026 | FDA letter ↗ |
“Your facility’s drug products, such as Semaglutide Injection 1mg/0.2ml and Tirzepatide Injection 2.5mg/0.5ml, did not include the following on the label: “Office Use Only.” 2. Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).”FDA warning letter to Tailstorm Health Inc. dba Medivant Health, Apr 8, 2025 · read the full letter on fda.gov ↗
What this is and is not.A warning letter is FDA’s statement of what it considers significant violations. It is an allegation, not a court finding, and the firm can respond. A closeout letter is posted when FDA confirms the violations were corrected.
Source
Every field above is copied from FDA’s page for this letter, read Oct 3, 2026. The letter on fda.gov ↗ · All 161 GLP-1 warning letters