FDA 483 - UBE Corporation - September 28, 2017

An FDA inspection of Ube Industries, Ltd. dba Ube API and Intermediates Factory in Ube, Japan, revealed significant deficiencies in their quality unit's oversight of cGMPs for active pharmaceutical ingredients. The firm failed to maintain electronic raw data, lacked adequate audit trails for laboratory instruments and manufacturing control systems, and had uncontrolled issuance of critical cGMP worksheets. These issues indicate a systemic breakdown in data integrity and quality management.