GenoGenix: 503B peptide compounder profile

We include GenoGenix not as a recommendation but as a documented cautionary case: a peptide-heavy 503B whose FDA inspection surfaced exactly the risks the peptide gray market is warned about — ineligible bulk substances, sterility/endotoxin failures, and sub-potent products.

Facility & compounding

GenoGenix (Boca Raton, FL) is on the FDA Registered Outsourcing Facilities list [2] and marketed itself as a 503B supplying doctors’ offices, med spas, and clinics [3]. Its catalog was peptide-heavy — dozens of lyophilized peptides and nasal sprays. Per FDA’s warning letter, products included peptides such as Epithalon, Thymosin Beta-4, and 5-Amino-1MQ; NAD+; and repackaged GLP-1s (semaglutide, tirzepatide, retatrutide) [1]. Accreditation: no PCAB listing was found in ACHC’s directory.

Regulatory record

This is the core of the profile, and every fact here is from FDA’s own warning letter (#718739, dated January 20, 2026), which followed a July 14–18, 2025 inspection [1]. Per that letter, FDA cited:

• compounding with bulk drug substances not eligible for 503B use (5-Amino-1MQ, NAD+);
• insanitary conditions and aseptic-processing / CGMP violations;
• sub-potent products (methylcobalamin measured at 65.3% of label; a B-complex product at 43.1%);
• a NAD+ lot with 3,360 EU/mL of endotoxin that FDA links to three patients sent to the emergency room;
• repackaged GLP-1s and Thymosin Beta-4 handled as unapproved new drugs.

FDA states the firm ceased production/distribution and initiated a voluntary recall on July 30, 2025 [1]. These are FDA’s inspection findings as stated in the warning letter, dated to our review.

The read

GenoGenix is the concrete version of the warning we give across this site about gray-market peptide sourcing: when a compounder uses ineligible bulk substances and its sterility controls fail, real patients can be harmed. It belongs in this directory for completeness and as a caution — not as an endorsement. Anyone evaluating a peptide compounder should treat a record like this as disqualifying until independently resolved.

References

1. FDA — Warning Letter to GenoGenix LLC (#718739, 2026-01-20). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/genogenix-llc-718739-01202026 (accessed 2026-07-01)
2. FDA — Registered Outsourcing Facilities (503B) list. https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities (accessed 2026-07-01)
3. GenoGenix — product storefront. https://shop.genogenix.com/ (accessed 2026-07-01)