FDA 483 - BeiGene, USA Inc. - November 13, 2023

An FDA inspection conducted at BeiGene USA Inc. from October 30 to November 13, 2023, identified significant deficiencies in the company's adverse event reporting and clinical study oversight processes. The inspection, which covered both post-marketing adverse drug experiences (PADE) and sponsor responsibilities, highlighted three primary observations. Firstly, BeiGene failed to report eight serious and unexpected adverse drug experiences to the FDA within the mandated 15 calendar days, with one notable delay extending 239 days. Secondly, the firm lacked formal written procedures for surveilling post-marketing adverse drug experiences, specifically concerning adverse event monitoring from social media platforms. Thirdly, BeiGene did not ensure proper monitoring of a clinical study. This included instances of unreported or delayed safety event communications to Institutional Review Boards/Ethics Committees, insufficient information on certain event outcomes, and failure to report events to the sponsor within protocol-defined timelines. Furthermore, an analysis of clinical operations revealed over 2,000 data queries with excessively long resolution times, some taking up to four years, a problem exacerbated by an inadequate Standard Operating Procedure lacking specified query resolution timelines. These observations indicate non-compliance with FDA regulations governing drug safety reporting and clinical trial conduct. BeiGene USA Inc. is expected to address these findings with comprehensive corrective and preventive actions.