FDA 483 - Biogen MA Inc. - March 23, 2017

Biogen, a biomanufacturer in Research Triangle Park, NC, was cited for multiple deficiencies during an FDA inspection. Observations included issues with validated computer system updates, deficient product contamination investigations, inadequate material tracking, untimely change controls, insufficient quality oversight in Annual Product Reviews, and inadequate shipping qualification studies. These issues indicate a lack of robust control over critical manufacturing processes and quality systems.