FDA 483 - Sumitomo Dainippon Pharma Co., Ltd. - April 16, 2019

An FDA inspection of Sumitomo Dainippon Pharma Co. Ltd. in Oita City, Japan, an API and Sterile API Manufacturer, revealed significant deficiencies in their sterile manufacturing processes. Observations included failures to establish and follow procedures to prevent microbiological contamination, inadequate environmental monitoring in aseptic processing areas, and a lack of validation for environmental monitoring media to recover microorganisms. These issues indicate a potential risk to the sterility and quality of their drug products.