FDA 483 - Toyobo Co. Ltd. - February 25, 2021

Toyobo Co. Ltd. in Otsu, Shiga, Japan, a sterile drug manufacturer, was cited for significant deficiencies across its quality system. Observations included failures in discrepancy review, environmental monitoring, aseptic practices, laboratory record completeness, and quality unit oversight, indicating a systemic lack of adherence to GMP principles and data integrity. The firm's practices showed issues with data integrity, personnel training, and validation of critical systems.