What FDA’s record states
| Field | What FDA’s record states | Source |
|---|---|---|
| Recipient | www.semaspace.com | FDA letter ↗ |
| Location | Not published by FDA | n/a |
| Letter date | Oct 2, 2023 | FDA letter ↗ |
| Posted by FDA | Oct 10, 2023 | FDA index ↗ |
| Issuing office | Center for Drug Evaluation and Research | CDER | FDA letter ↗ |
| Subject | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | FDA letter ↗ |
| MARCS-CMS number | 665848 | 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 ↗ |
“As discussed below, FDA has observed that www.semaspace.com introduces into interstate commerce unapproved and misbranded semaglutide drug products. There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs.”FDA warning letter to www.semaspace.com, Oct 2, 2023 · 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
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