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

An FDA inspection of BEIGENE USA INC in San Mateo, CA, revealed significant deficiencies in their pharmacovigilance and clinical trial oversight. The firm failed to timely report serious adverse drug experiences, lacked written procedures for post-marketing surveillance from social media, and exhibited inadequate monitoring of clinical studies leading to delayed reporting of safety events and unresolved data queries. These issues indicate a systemic failure to comply with regulatory requirements for drug safety and clinical research.