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 three significant deficiencies. The firm failed to establish appropriate sampling criteria for incoming raw materials, lacked adequate procedures to prevent objectionable microorganisms in non-sterile drug products, and did not maintain complete backups of electronic data from critical visual inspection equipment. These observations indicate a need for improved quality control and data integrity practices.