FDA 483 - Daiichi Sankyo Chemical Pharma Co., Ltd. - July 01, 2021

This 483 report for Daiichi Sankyo Chemical Pharma Co., Ltd. in Gunma, Japan, details significant deficiencies in manufacturing process control, quality unit separation, deviation and CAPA management, facility cleaning procedures, and pest control. The observations indicate a lack of adherence to established procedures, ineffective corrective actions, and potential risks to product quality and facility integrity. The inspection identified repeated issues, highlighting systemic problems in quality oversight and operational compliance.