GenoGenix LLC
FDA 503B outsourcing facility
Raton, Florida
Key Takeaways
- FDA-registered 503B outsourcing facility since 2025
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: July 18, 2025
- 57 FDA drug recalls on record (2025)
About this facility
A 503B outsourcing facility is registered with the FDA under the Drug Quality and Security Act and may compound sterile medications in bulk without patient-specific prescriptions, under cGMP manufacturing standards. How federal compounding status works.
FDA registration and inspection record
- First registered with FDA
- February 4, 2025
- Most recent registration
- February 11, 2026
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- July 18, 2025
The FDA last inspected GenoGenix LLC on July 18, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. The FDA has not yet determined whether further action will be taken.
FDA recall history
GenoGenix LLC has 57 FDA drug recalls on record in 2025, based on the FDA enforcement database. Breakdown: 1 Class I, 56 Class II.
Recall reasons on record include lack of assurance of sterility; microbial contamination of sterile products: elevated endotoxin levels.
| Date | Class | Product | Reason |
|---|---|---|---|
| July 2025 | Class II | Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 | Lack of Assurance of Sterility |
| July 2025 | Class II | Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 | Lack of Assurance of Sterility |
| July 2025 | Class II | GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility |
| July 2025 | Class II | Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility |
| July 2025 | Class II | Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility |
Showing the 5 most recent of 57 recall events.
FDA recall classes signal severity, not intent: Class I means a reasonable probability of serious harm, Class II a temporary or reversible risk, Class III a violation unlikely to cause harm. Sterile compounders routinely recall lots as a precaution. FDA definitions.
Compounded peptides and GLP-1s
GenoGenix LLC has not assigned NDCs or filed product reports in the most recent FDA reporting periods. 503B outsourcing facilities are a primary supply route for compounded peptides and GLP-1s during FDA-listed shortages; PeptideGrids grades the evidence for each, including Semaglutide, Tirzepatide, BPC-157, Retatrutide. Browse the GLP-1 and therapeutic peptide databases.
Location
2840 Nw 2nd Ave Ste 204, Boca Raton, FL 33431-6692
Satellite and street imagery via Esri. Open larger map.
Contact
FDA-registered contact: Horace Smith, 1-561-264-7303. Source: the facility's FDA outsourcing registration.
License verification
503B outsourcing facilities are also licensed by the state board of pharmacy. Verify the current license status of GenoGenix LLC with the Florida Board of Pharmacy.
503B facilities in Florida
Florida has 16 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in Florida.
Frequently asked questions
Is GenoGenix LLC registered with the FDA?
Yes. GenoGenix LLC is a registered 503B outsourcing facility, first registered with the FDA on February 4, 2025 and most recently registered on February 11, 2026.
Has GenoGenix LLC been inspected by the FDA?
The FDA last inspected GenoGenix LLC on July 18, 2025. A Form FDA 483 was issued.
Has GenoGenix LLC had any FDA drug recalls?
GenoGenix LLC has 57 FDA drug recalls on record (2025) in the FDA enforcement database.
What does GenoGenix LLC compound?
GenoGenix LLC has not filed product reports with NDC-assigned drugs in the most recent FDA reporting periods.
Where is GenoGenix LLC located?
GenoGenix LLC is located in Raton, Florida (2840 Nw 2nd Ave Ste 204).
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026. Recall history from the FDA openFDA drug enforcement database, retrieved June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by GenoGenix LLC. Listings, registration, inspection, and recall data are reported from public FDA records for informational purposes only. A recall or inspection finding is not an accusation of current wrongdoing. This is not medical or legal advice. To request a correction, see our corrections policy.