FDA 483 - Biogen U.S. Corporation - August 19, 2022

Biogen U.S. Corporation in Research Triangle Park, NC, underwent an FDA inspection of its drug manufacturing facility. The inspection identified a critical lapse in data integrity and control, specifically the absence of procedures to review calculations within an un-validated Excel spreadsheet. This spreadsheet was used for establishing Assay Acceptance Criteria for Tofersen drug substance and drug product, indicating a failure to ensure accuracy in related data systems.