Quality Composition – Scientifically Sophisticated, FDA and DEA Inspected, In-House Quality Testing Labs Deliver Peace of Mind
At Fagron Sterile Services US (FSS) we don’t just rely on a third party to ensure the quality of our products like many Sterile-to-Sterile compounders.
We take ownership of our entire process and offer options that not only provide better value to you and the patients you serve, but allow for industry-leading quality control over the entire process from raw materials to finished goods.
FSS strives to achieve the highest quality standards in the industry, including compliance with cGMP operations and all FDA and DEA regulations.
- 100% of batches are tested for sterility, P.M., and potency
- State-of-the-art 24/7/365 environmental monitoring
- Multiple VHP isolators for sterility testing
- 16 ISO 5 classified aseptic processing environments
- Industry-leading automation technology
- In house lab capabilities for all cGMP finished drug testing requirements, including potency, sterility, endotoxin and particulate matter
Fagron Sterile Services US is a leading 503B outsourcing solution you can rely on — from Quality to committed supply and customer service. Set up a free consultation to learn more about our Sterile-to-Sterile and API-to-Sterile services. Learn more today!