Beigene USA, Inc. – FDA EIR, Jun 2, 2021

An FDA Bioresearch Monitoring (BIMO) inspection was conducted at BeiGene USA, Inc., San Mateo, CA, from May 19 to June 2, 2021. The inspection, carried out under FDA Compliance Program 7348.810, primarily reviewed the supplemental New Drug Application (NDA 213217 S-005) for Zanubrutinib (Brukinsa®) and its associated clinical trial Protocols BGB-3111-214 and BGB 3111-AU-003. A key finding was that an FDA Form 483, Inspectional Observations, was not issued to BeiGene USA, Inc., indicating a generally compliant inspection outcome. However, several