Sterile Compounding Services
Sterile-to-Sterile | API-to-Sterile | Biologic
Produced with industry-leading automation and quality control, delivered with top-tier service.
7,300+ customers choose FSS US as their trusted 503B compounder — along with some of the largest GPOs and IDNs in the country.
503B Human Drug Outsourcing
Fagron Sterile Services is registered with the DEA and FDA as a 503B Outsourcing Facility with an exclusive focus on sterile products. This dedication to sterile products has led to the development of technology and systems that enhance quality assurance and patient safety. We are State Board of Pharmacy licensed, registered with the FDA as a 503B outsourcing facility and follow cGMP, GDP and cGLP guidelines.
Efficiency by Design
Fagron Sterile Services is confident in our people and our abilities for a good reason. We deliver your compounded sterile preparation on time and on budget with principled agility and personal accountability. The efficiency fostered by our integral relationships with our clients and hands-on management style promotes personal accountability in everything we do.
Attention to Detail
With Fagron Sterile Services you will experience a level of service and accountability that has been lost in layers of red tape and bureaucracy at other companies. Couple this focus with our principled agility and we will help you keep pace with the most demanding of projects and timelines.
- Process Validation: Aseptic Fill, Sterilization, Depyrogenation, All Compounding Activities, IQ, OQ, PQ on all equipment
- Validation of Testing Methods: Stability Over Time, Endotoxin, Fungal, Sterility
- Validated SOPs