FDA record · 503B outsourcing facility

GenoGenix LLC: FDA 503B outsourcing facility record

GenoGenix LLC in Raton, FL is on FDA's register of 503B outsourcing facilities. Registered since Feb 4, 2025; last FDA inspection Jul 18, 2025; Form 483 issued at that inspection: Yes; action FDA lists: Open. Register updated by FDA Sep 30, 2026.

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

Status: Registered since Feb 4, 2025; last FDA inspection Jul 18, 2025.

What FDA’s register states

FDA register entry for GenoGenix LLC
Field	What FDA’s record states	Source
Facility	GenoGenix LLC	FDA register
Location	Raton, FL	FDA register
First registered	Feb 4, 2025	FDA register
Most recent registration	Feb 11, 2026	FDA register
Last FDA inspection	Jul 18, 2025	FDA register
Form 483 issued	Yes	FDA register
Recall conducted	Not published by FDA	FDA register
Action based on last inspection	Open	FDA register
Earlier compounding action	Not published by FDA	n/a
Intends to compound sterile drugs from bulk	Yes	FDA register

Registration is a filing, not an approval.A Form FDA 483 lists what investigators observed; in FDA’s words it “does not constitute a final agency determination of whether any condition is in violation of the FD&C Act or any relevant regulations.” “Open” means FDA has not determined whether further action will be taken.

GLP-1 warning letters to a firm of this name

Matched by name; FDA’s letter gives the address it was sent to.

Source

Copied from FDA’s Registered Outsourcing Facilities table ↗, updated by FDA Sep 30, 2026, read Oct 3, 2026. The table does not include State Board of Pharmacy actions. All 98 registered facilities