FDA 483 - BeOne Medicines USA, Inc. - February 17, 2026

An FDA inspection of BeOne Medicines USA, Inc. in Pennington, NJ, revealed a significant failure to adhere to clinical study protocols. The firm enrolled a subject into a study without required hepatitis C screening and failed to obtain necessary consent for a tumor biopsy, leading to the biopsy not being shipped for pathology confirmation. These issues highlight critical deviations in the conduct of clinical trials and subject protection.