Quality

How do you incorporate industry-leading product safety standards and reliable supply, without contributing to skyrocketing healthcare costs? You partner with an organization built on decades of compounding experience, centered around Quality and intensely focused on customers and the patients they serve.

Fagron Sterile Services quality associate

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!