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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 October 2026
Status: Registered since Feb 4, 2025; last FDA inspection Jul 18, 2025.

What FDA’s register states

FDA register entry for GenoGenix LLC
FieldWhat FDA’s record statesSource
FacilityGenoGenix LLCFDA register
LocationRaton, FLFDA register
First registeredFeb 4, 2025FDA register
Most recent registrationFeb 11, 2026FDA register
Last FDA inspectionJul 18, 2025FDA register
Form 483 issuedYesFDA register
Recall conductedNot published by FDAFDA register
Action based on last inspectionOpenFDA register
Earlier compounding actionNot published by FDAn/a
Intends to compound sterile drugs from bulkYesFDA 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

GenoGenix LLCJan 20, 2026

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

GLP-1 recalls by a firm of this name

  • Class II, ongoing, reported Oct 15, 2025Lack of Assurance of SterilityD-0083-2026 · Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton,...
  • Class II, ongoing, reported Oct 15, 2025Lack of Assurance of SterilityD-0091-2026 · Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Ra...
  • Class II, ongoing, reported Oct 15, 2025Lack of Assurance of SterilityD-0092-2026 · Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204...

Matched by name, from FDA’s enforcement reports (updated by FDA Sep 30, 2026). Every GLP-1 recall

Source

Copied from FDA’s Registered Outsourcing Facilities table ↗, updated by FDA Sep 30, 2026, read Oct 7, 2026. The table does not include State Board of Pharmacy actions. All 98 registered facilities