FDA 483 - Daito Pharmaceutical Co., Ltd. - January 31, 2020

The FDA inspection of Daito Pharmaceutical Co., Ltd. in Toyama, Japan, revealed significant deficiencies across laboratory controls, data integrity, equipment management, and quality systems. Repeated observations from a previous inspection indicate persistent issues with computerized system controls, supplier evaluation, and GMP documentation. The findings suggest a systemic lack of control over critical manufacturing processes and data.