Biogen MA Inc. – FDA 483, Jun 16, 2021

An FDA inspection of Biogen Inc.'s drug substance manufacturing facility in Research Triangle Park, NC, revealed significant deficiencies across multiple quality systems. Observations included inadequate documentation for training samples, poor maintenance of equipment and facilities, and failures in contamination control. The firm also lacked complete method validation for bioburden detection, had an inadequately specified GMP utility, and demonstrated non-adherence to several standard operating procedures.