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

A pre-approval inspection of Biogen Inc.'s drug substance manufacturing site in Research Triangle Park, NC, was conducted by the U.S. Food and Drug Administration (FDA) from June 7 to June 16, 2021. The inspection aimed to assess the site's readiness for approving a new drug application. At the conclusion, a 6-item Form FDA 483 was issued, detailing several objectionable conditions across five systems including Quality, Facilities and Equipment, Manufacturing, Materials, Packaging and Labeling, and Laboratory. Key issues identified included inadequate documentation and traceability for quality control training samples, deficiencies in maintaining equipment and facilities to ensure drug substance quality (such as chipping paint, deteriorated seals, and rust), and a lack of effectiveness checks for sanitization procedures of long-term storage vessels which had previously experienced bioburden contamination events. Furthermore, method validation for bioburden detection in certain storage conditions was incomplete, a GMP utility was found to be inadequately installed, and several standard operating procedures were either not followed or deemed insufficient, including those related to equipment covering and inspection for debris. Consequently, the FDA's initial recommendation was to withhold approval of the application. This decision is pending the company's adequate response to these objectionable conditions, with the initial responses to conditions 1 and 2 already deemed inadequate.