Biogen U.S. Corporation – FDA EIR, May 4, 2018

Biogen US Corp.'s facility in Research Triangle Park, North Carolina, underwent an FDA pre-approval inspection from April 30 to May 4, 2018. The inspection, conducted to support an application to add Biogen as a drug product manufacturer, focused on manufacturing areas, quality control laboratories, and related systems, under general FDA guidelines for therapeutic drug products and pre-approval investigations. A previous surveillance inspection in late 2015 had identified several deficiencies, including issues with aseptic processing, adherence to written procedures, and equipment cleaning, resulting in a "Voluntary Action Indicated" classification. A key outcome of this current inspection was the verification that Biogen had successfully implemented corrective actions for these earlier findings. However, the recent review led to two new observations, formally noted on an FDA-483 form. The primary issues identified were: 1) a failure to consistently follow written production and process control procedures related to the qualification of vendors; and 2) the cleaning procedure for a critical piece of equipment, specifically the exterior surface of an apparatus within the filling room's Grade C area, lacked adequate supporting data from the firm’s disinfectant efficacy study. In response to these findings, Biogen's management committed to submitting a detailed plan addressing the observations within 15 business days, in accordance with expectations for maintaining compliance with current Good Manufacturing Practices. No samples were collected, and the inspection was conducted without any refusals of access.