FDA 483 - Sumitomo Dainippon Pharma Co., Ltd. - July 11, 2025

An unnamed sterile Active Pharmaceutical Ingredient (API) and Finished Product Drug Manufacturer located in Oita, Oita, Japan, was inspected by the FDA from July 3 to July 11, 2025. The inspection resulted in several significant observations regarding the firm's adherence to current Good Manufacturing Practices (cGMP) for sterile drug products. Key violations included a lack of established, written, and followed procedures to prevent microbiological contamination. Inspectors observed improper aseptic techniques, such as operators leaning into critical Grade A filling areas and handling sterile components with non-sterile gloves. Furthermore, personal protective equipment, specifically eye covers, were found to have design flaws that compromised sterility. The FDA also noted deficiencies in the validation of aseptic processes. Airflow visualization studies were deemed inadequate due to issues with smoke uniformity, buoyancy, and improper methodology. Additionally, the firm failed to provide calibration and qualification documentation for rented environmental monitoring equipment. Cleaning and disinfection practices in aseptic processing areas were found to be deficient. Disinfectant efficacy studies lacked demonstration of adequate log reduction for spore-forming microbes on all surfaces and failed to assess sporicidal effects on all materials. Cleaning procedures did not align with validated studies, exhibiting incorrect contact times and non-unidirectional movements. Finally, inadequate controls over computer systems, specifically non-viable particle counting equipment, allowed all operators access to change critical date and time settings. The firm is required to submit a comprehensive response detailing corrective and preventive actions to address these observations.