FDA 483 - DiAgam Societe Anonyme (S.A.) - December 18, 2025

An FDA inspection of Diagam Societe Anonyme (S.A.) in Ath, Belgium, revealed significant deficiencies in their manufacturing processes for Alpha2-Macroglobulin immunoturbidimetry IVD kits. The firm failed to adequately validate critical capping processes and analyzer testing, and operated equipment outside validated parameters. Additionally, procedures for equipment maintenance, finished device acceptance, and in-process product control were found to be inadequate.