Fagron Sterile Services US (FSS)
Leanne Agostino MS, MBA is an accomplished professional with extensive experience in manufacturing operations and regulatory compliance within the healthcare sector. Currently serving as Director of Manufacturing Operations at Fagron Sterile Services US since September 2019, previous roles include Director of Manufacturing and Senior Manager of Production at Fresenius Kabi USA, and Production Manager at Ocular Therapeutix, Inc. Leanne has demonstrated expertise in implementing aseptic techniques, overseeing production schedules, ensuring compliance with quality systems, and leading teams in various manufacturing settings. Educational qualifications include an MBA from the University of Massachusetts Lowell, an MS in Regulatory Affairs from Northeastern University, and a BS in Health Science from the Massachusetts College of Pharmacy and Health Sciences.
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Fagron Sterile Services US (FSS)
Fagron Sterile Services US operates two cGMP compliant DEA/FDA-registered and inspected 503B Outsourcing Facilities (Wichita, KS & Boston, MA) delivering a reliable supply sterile of medications to patient-focused healthcare facilities across the United States. FSS specializes in Sterile-to-Sterile, API-to-Sterile, and Biologics, offering an robust portfolio of preparations including ready-to-administer IV bags and OR syringes, pain management, ophthalmics, dialysis, urology, and specialty solutions. OUR STORY: Together we create the future of personalizing medicine. Founded in 1990, in the Netherlands, Fagron engineered one of the largest quality networks, with certified auditors performing supplier qualifications, serving 35 countries, to deliver high-quality products to more than 200,000+ customers worldwide. In doing so, Fagron has become the global leader in pharmaceutical compounding. In 2010, Fagron entered the North American market. As part of the only vertically integrated pharmaceutical company dedicated to sterile compounding, Fagron's 503B facilities (FSS) provide pharmaceutical outsourcing solutions on a comprehensive level to meet customer needs across the continuum of care. As a forward-thinking pharmaceutical supplier, Fagron recognized the opportunity to serve our customers better by acquiring JCB Laboratories, in December, 2013. JCB Labs was at the forefront of shaping industry standards in sterile preparations for nearly two decades and was one of the first companies in the country to register with the FDA. Building off JCB’s experience, Fagron built FSS US, a state-of-the-art manufacturing facility in Wichita, KS, because we believe in the need for regulated sterile preparations. In 2022, Fagron added a second state-of-the-art facility in Boston, MA, through the acquisition of Fresenius Kabi's compounding division. Choose Quality. Choose Consistency. Choose Fagron Sterile Services US, A 503B Outsourcing Solution You Can Rely On!