FDA 483 - Toyobo Co. Ltd. - February 22, 2023

An FDA inspection of Toyobo, Co., LTD in Otsu, Shiga, Japan, a sterile drug manufacturer, revealed significant deficiencies. The firm failed to adequately validate aseptic sterilization processes, establish proper production and process controls for light-sensitive APIs, and ensure scientifically sound laboratory testing for bacterial endotoxins. Additionally, procedures for preventing microbiological contamination were not followed, and complaint investigations lacked adherence to established quality information handling rules.