FDA 483 - Daito Pharmaceutical Co., Ltd. - December 19, 2023

An FDA inspection of Daito Pharmaceutical Co., Ltd. in Toyama-City, Japan, revealed significant deficiencies in manufacturing controls and quality assurance. The firm lacked adequate written procedures for equipment cleaning and cross-contamination monitoring, and failed to qualify non-pharmacopeia standards used for raw material testing against USP reference standards. These issues indicate a lack of robust controls to ensure drug product quality and purity.