Origin Biologics takes extreme measures to ensure the recovery and processing of all donated tissue meets the guidelines set forth by the U.S. Food and Drug Administration (FDA).
Origin Biologics has the highest regard for the safety of our products, patients, and employees. In support of our mission, we are committed to providing quality products that meet the needs of our customers, regulatory requirements, and our own standards, which are driven by the leadership of management and supported by dedicated employees. This will be achieved through our commitment to maintain an effective and risk-based Quality Management System.
Origin Biologics performs several bacterial cultures on each tissue recovered and processed. The bacterial culturing is done at the time of recovery and again at final packaging. Aseptic tissue products must be culture negative at the time of final packaging. Any tissue contaminated with pathogenic microorganism are not released for transplant. The technologist’s documents each of the recovery and processing steps, and quality assurance personnel monitor and maintain these records.
Allograft Tissues from Origin Biologics are sterilized in their final packaging to ensure the highest quality and patient safety. All products are frozen and configured at room temperature and ready to use. Our packaging processes ensure allografts arrive to our customers in the best possible condition to facilitate a successful transplantation.
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