As part as US FDA Licensed Establishment, DIAGAST is inspected every 2 years for the manufacturing of Red Blood Cells, blood grouping reagents and bulk blood gouping reagents for further manufacture (FFMU). A routine FDA inspection was carried out in our premises on 13 to 21 February 2017 by an inspector from the Team Biologics of the Center for Biologics Evaluation and Research (CBER). We are proud to announce that we have successfully passed this inspection.
This inspection has covered the company's Quality Management System, Corrective and Preventive Action System as well as Production and Process Control System, according to FDA 21 Code of Federal Regulations part 600, 601, 660 C and D and 820. It has demonstrated the DIAGAST high level of Good Manufacturing Practises with continuous improvement, as a guarantee for new and existing customers of our high management and quality standards
Great thanks to DIAGAST people for this accomplishment sourced by daily Creativity, Performance and Commitment, our 3 core values.