FDA record · warning letter

FDA warning letter: GenoGenix LLC (Jan 20, 2026)

On Jan 20, 2026, FDA issued a warning letter to GenoGenix LLC of Boca Raton, FL under the subject "Compounding Pharmacy/Adulterated Drug Products". It names semaglutide, tirzepatide, retatrutide. Open: no closeout letter published as of Oct 3, 2026.

Julian CaraulaniFounder, PriceTracker GLP-1FDA record read Oct 3

Status: Open: no closeout letter published as of Oct 3, 2026.

What FDA’s record states

FDA record for the warning letter to GenoGenix LLC
Field	What FDA’s record states	Source
Recipient	GenoGenix LLC	FDA letter
Location	Boca Raton, FL	FDA letter
Letter date	Jan 20, 2026	FDA letter
Posted by FDA	Mar 3, 2026	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	Compounding Pharmacy/Adulterated Drug Products	FDA letter
MARCS-CMS number	718739	FDA letter
GLP-1 drugs named	Semaglutide, Tirzepatide, Retatrutide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“Furthermore, you do not have any FDA-approved applications on file for the drug products that you repackage, such as Semaglutide, Tirzepatide, and Retatrutide. Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 331(d)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug.”FDA warning letter to GenoGenix LLC, Jan 20, 2026 · 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