FDA 483 - Daiichi Sankyo, Inc. - August 01, 2025

An FDA inspection of Daiichi Sankyo, Inc. in Basking Ridge, NJ, revealed significant deficiencies in their Risk Evaluation and Mitigation Strategy (REMS) program. The firm failed to identify and address non-compliant healthcare providers and ensure prescribers reported serious adverse events. Additionally, the company did not maintain adequate drug distribution and dispensing records to ensure restricted distribution, allowing product to be dispensed by non-certified prescribers and transferred to non-certified locations.