GenoGenix Strengthens Quality and Expands Operations Following FDA Audit
Boca Raton, FL – October 1, 2025 — GenoGenix, LLC, a biotech company with an FDA-registered 503B outsourcing facility, today shared updates on steps it is taking after the FDA’s recent routine audit.
Reviewing FDA Audit Findings
The inspection identified gaps in training and documentation within sterile manufacturing. No issues were found in peptide or non-sterile manufacturing, and ongoing product testing has shown no safety or efficacy concerns.
GenoGenix’s Action Plan
In response, GenoGenix has already submitted its action plan and is working with industry experts who bring decades of regulatory and quality experience to make sure improvements are put in place quickly and effectively.
What’s happening now:
- Training programs and documentation are being updated and strengthened
- New quality and compliance team members have joined to support long-term growth
- Two new state-of-the-art facilities are under construction to expand capacity
- Expanded production lines have already reduced order turnaround to 2–3 business days, with all shipments going out UPS Next Day Air
“We take the FDA’s feedback seriously, and we’re moving fast to raise the bar even higher,” said Sam Miron, Founder & CEO of GenoGenix. “Our customers count on us for safe, effective, and reliable products, and that trust is something we will always work hard to protect.”
About GenoGenix
GenoGenix, LLC is a biotech company with an FDA-registered 503B outsourcing facility with certified cleanrooms, instruments and equipment dedicated to producing high-quality compounded medications for healthcare providers nationwide. The company partners with physicians to deliver reliable, pharmaceutical-grade products that support patient health and clinical innovation.
Media Contact:
Joel Cummings
Co-Founder
pr@genogenix.com
Frequently Asked Questions
What Is an FDA Audit?
A routine FDA audit for 503B outsourcing facilities happens at least once every two years. This ensures compliance with Good Manufacturing Practices (GMP) to protect patient safety. GenoGenix’s recent audit highlighted areas for improvement in sterile manufacturing, which we are addressing with urgency and expertise.
What does an FDA audit mean for GenoGenix customers?
Routine audits help ensure our products meet the highest safety standards.
Are the products safe?
Yes. The FDA’s observations did suggest additional testing, all current testing supports the safety and efficacy of our products.
How is GenoGenix improving sterile manufacturing?
We have taken extreme measures to strengthen the quality systems and assuring the public of its products safety moving forward. Including updating training, hired compliance experts, and building new facilities to exceed FDA standards.