FDA 483 - Sumitomo Dainippon Pharma Co., Ltd. - August 07, 2025

An FDA inspection of Sumitomo Pharma Co., Ltd. in Suzuka, Japan, a drug manufacturer, revealed significant deficiencies in quality control. Observations included inadequate sampling procedures for raw materials, insufficient microbial control strategies for non-sterile drug products, and a failure to maintain complete backups of electronic data from visual inspection equipment. These issues indicate a need for improved quality systems to ensure product safety and data integrity.