Quality by Design – Including FDA and DEA Inspected, In-House Quality Testing Labs for 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 in our FDA inspected labs over the entire process from raw materials to finished goods. Learn more about our API-to-Sterile services today.
FSS strives to achieve the highest quality standards in the industry, including complying with all FDA and DEA regulations.
- 100% of batches are tested for sterility, P.M., and potency
- State-of-the-art environmental monitoring
- Multiple VHP isolators for sterility testing
- 16 ISO 5 classified aseptic processing environments
- Industry-leading automation
- 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. Learn more today!