FDA 483 - FUJIFILM Diosynth Biotechnologies Denmark ApS

Biogen (Denmark) Manufacturing ApS, a biological drug substance manufacturer in Hillerød, Denmark, was cited for significant deficiencies during an FDA inspection from October 7-11, 2019. Observations included issues with bioburden control, inadequate qualification of critical utilities, insufficient electronic data integrity controls, and failures in equipment validation and revalidation. These findings indicate a lack of robust quality systems for manufacturing and data management.