What FDA’s record states
| Field | What FDA’s record states | Source |
|---|---|---|
| Recipient | iVisitDoc, Inc. dba iVisitDoc | FDA letter ↗ |
| Location | Indianapolis, IN | FDA letter ↗ |
| Letter date | Sep 9, 2025 | FDA letter ↗ |
| Posted by FDA | Sep 16, 2025 | FDA index ↗ |
| Issuing office | Center for Drug Evaluation and Research (CDER) | FDA letter ↗ |
| Subject | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) | FDA letter ↗ |
| MARCS-CMS number | 716826 | FDA letter ↗ |
| GLP-1 drugs named | Semaglutide | FDA letter ↗ |
| Response letter | Not published by FDA | FDA letter ↗ |
| Closeout letter | Not published by FDA | FDA letter ↗ |
“The following claims concerning compounded semaglutide products appear on your website: • “Compounded semaglutide from iVisitDoc has the same active ingredients as Wegovy and Ozempic, but doesn’t come in a preloaded pen.” • “Clinically Validated Ingredients” Compounded drug products are not FDA-approved.”FDA warning letter to iVisitDoc, Inc. dba iVisitDoc, Sep 9, 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.
Other GLP-1 letters FDA issued that week
Chengdu Brilliant Biopharmaceutical Co., Ltd.Sep 11, 2025motionpharmacy.comSep 10, 2025All American WellnessSep 9, 2025Amazing MedsSep 9, 2025ASN-LABSSep 9, 2025Bioverse, Inc. dba BioverseSep 9, 2025Body Good StudioSep 9, 2025Canada Med StopSep 9, 2025Cosmo Medical Spa dba Cosmo Med SpaSep 9, 2025CurexSep 9, 2025directmeds.com, Inc. dba DirectMedsSep 9, 2025Dr. Gater’s Weight Loss & WellnessSep 9, 2025
And 48 more in the full list.
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