The capacity to care
Multi-site operations — prioritizing communication, collaboration, and patient safety — designed for demand, engineered for efficiency.
State-of-the-art 503B outsourcing operations
503B Outsourcing facility
Centrally located in the US, our Wichita operation features purpose-built areas for manufacturing, quality control, analytical laboratories, labeling, product storage, packaging, shipping and administration.
185,000 ft²
Capacity across 2 state-of-the art operational facilities to support 503B sterile compounding
Sterile compounding
16 ISO-5 manufacturing areas including dedicated USP-800 compliant suites and drug processing
Controlled substances
Capabilities support secure class 2 through 5 DEA manufacturing storage, and distribution
Automation
Enhances safety and scalability with syringe filling, labeling, and semi-automated bag filling
503B outsourcing facility
Strategically located in the Northeast, our Boston operation features precision-engineered areas for manufacturing, quality control, microbiology, labeling, product storage, packaging, shipping and administration.
49,000 ft2
German-engineered state-of-the art operational facility to support 503B sterile compounding
Sterile compounding
8 dedicated ISO-5 manufacturing lines including automation capabilities
Controlled substances
Capabilities support secure class 2 through 5 DEA manufacturing storage, and distribution
Concierge delivery
Boston provides “white glove” delivery service to hospitals inside a 200-mile radius
Fagron North America headquarters
Located in downtown Austin, TX, our US HQ is the central hub for Fagron’s administrative and commercial operations across North America. Our Global HQ is located in Rotterdam, Netherlands.
Culture
Our teams collaborate to inspire innovation through our core values and family rules
Sustainability
Integrating social responsibility in everything we do while fostering transparency and teamwork
Accessibility
Empowering pharmacists to advance equitable access to essential medicine
Footprint
Five unique businesses, 10 facilities serving the needs of pharmacists across the US
Virtual facility tour
Join us for a personalized virtual tour of our state-of-the-art 503B facilities in Boston, MA, and Wichita, KS.
Hosted by leadership, these 3D tours highlight our DEA and FDA-registered, inspected sites built to support cGMP-compliant operations. Through quarterly metrics, virtual tours, and on-site audits, we foster transparency and trust, with advanced operations and quality-focused production to support your patient care needs.
Quality by design
Sophisticated in-house quality testing labs deliver peace of mind
100% of batches are tested
for sterility, particulate matter, and potency
State-of-the-art
24/7/365 environmental monitoring
Advanced sterility testing
Multiple VHP isolators enhance testing capabilities promoting patient safety
Comprehensive quality assurance
Automated systems ensure cGMP compliance and maintain high-quality standards.
Electronic quality management system (eQMS)
Centralized eQMS streamlines audits, document control, and batch review.
Batch release integrity
Every batch is thoroughly verified to meet specifications and regulatory compliance.
Quality-driven, cGMP compliant, outsourcing facilities
Delivering value to you and your patients
Control of incoming raw materials and components
Received materials and components are inspected in accordance with our internal specifications and as required, a review of the incoming Certificate of Analysis (COA) or Certificate of Conformity (COC) prior to release of the materials. For accurate tracking, each product is scanned to update our production system.
Material sanitization
FDA-approved sterile solutions and other drug components are then moved to the preparation area, where they undergo sanitization and decontamination by using approved cleaning agents before entering the ISO-certified clean rooms.
Manufacturing of sterile products
Sterile products are manufactured in controlled environments maintained by validated systems, with each step completed by trained and qualified FSS personnel. The entire manufacturing process uses validated equipment, and each step is meticulously documented. Environmental monitoring (EM) results are verified to be within specification for batch release and are trended as part of our comprehensive EM reports.
Quality Control testing
A rigorous Quality Control (QC) testing process is completed for every batch, utilizing our state-of-the-art technology QC laboratory instrumentation. This testing includes potency, particulate matter, endotoxin, pH, and sterility to support patient safety. In addition, all products complete required stability testing on qualified stability-indicating test methods to determine appropriate expiry dating.
Inspection, and labeling
Each batch produced undergoes 100% Visual Inspection by qualified FSS manufacturing personnel and Acceptance Quality Limit (AQL) inspection by qualified FSS Quality Control staff. Labeling of product is completed using FSS’s labels, adhering to ASTM, DQSA, and ISMP medication labeling standards. These labels standards help mitigate medication errors, enhancing the visibility of critical information, including presentation specifics, route of administration, storage requirements, expiration dating, and barcoding.
Quality assurance
Quality assurance maintains the overall cGMP systems for the facilities by managing an electronic Quality Management System, performing Internal Audits, ensuring each batch meets all specifications and compliance requirements before batch release.
Packaging & Shipping
Barcode scanning is utilized at multiple points in the order fulfillment process to ensure accuracy. Additionally, all sales orders are verified by dedicated personnel before departing from the facility. Shipment tracking information is then provided to the customer for visibility.
Frequently asked questions
All products are shipped via UPS Second Day service and expedited overnight shipping can be arranged upon customer request. If refrigerated temperature control is required, Fagron Sterile Services US ensures only validated packaging solutions are used to ensure a safe, stable CSP is delivered to your door.
Yes, Fagron Sterile Services US (FSS) is among the largest 503B Outsourcing Facilities in the country. At the Wichita facility, there is over 14,000 ft² of cGMP compliant cleanroom space and industry-leading automation. At the Boston facility, there is over 10,000 ft2 of cleanroom space.
Fagron Sterile Services US (FSS) uses the most current technology and reliable equipment for sterile product compounding. FSS regularly certifies its sterile compounding equipment with internal validation and adheres to a comprehensive set of Standard Operating Procedures covering process, equipment, personnel, environment, and validation.
Still have questions?
We are here to help. Call, email, or schedule a site visit today.
Speak with your personal representative today
Service is in our name and we can’t wait to partner with your patient-focused healthcare facility. Schedule a free consultation today to discuss your 503B outsourcing needs.
Globally and vertically integrated operations
Fagron’s 4k+ employees serve 30+ countries from 70+ facilities
Proactively supporting supply chain resiliency
Fagron’s global team of 100 supply chain experts leverage 3k+ suppliers
Diverse portfolio across the continuum of care
FSS supports patient care from the delivery room to the O.R.
including clinics
