FDA 483 - Biogen MA Inc.

Biogen, Inc. in RTP, NC, was inspected by the FDA, resulting in five observations related to significant deficiencies in their quality system. The inspection revealed failures in thoroughly investigating discrepancies, inadequate computer system controls, incomplete laboratory records, and issues with equipment logbook review and calibration records. These findings indicate a lack of robust controls over manufacturing and laboratory operations, particularly concerning data integrity and deviation management.