Beigene USA, Inc. – FDA EIR, Oct 22, 2021

An FDA inspection of BeiGene USA, Inc. in San Mateo, CA, was conducted from October 18-22, 2021. This comprehensive sponsor inspection, performed under the Bioresearch Monitoring Compliance Program, assessed BeiGene's oversight and activities for a clinical study supporting a Biologics License Application (BLA) for Tislelizumab. The inspection reviewed various aspects, including organization, personnel qualifications, monitoring procedures, quality assurance, safety reporting, data management, and record retention. At the inspection's conclusion, no significant deficiencies were identified, and no Form FDA-483 (Inspectional Observations) was issued, resulting in a "No Action Indicated (NAI)" classification. However, two items were discussed with management: the need for clearer linkage between BeiGene, Ltd.'s global vendor agreements and the named BeiGene USA/China sponsors, ensuring a single point of control for transferred responsibilities; and an internal Standard Operating Procedure (SOP) inaccurately stated a 30-day timeframe for updating ClinicalTrials.gov registrations, whereas the regulatory requirement is 21 calendar days. Management acknowledged these points, and a corrected SOP was immediately presented.