FDA 483 - Kyowa Kirin Co., Ltd. - August 30, 2021

An FDA inspection of Kyowa Kirin Co., Ltd.'s Takasaki Plant, a drug substance manufacturer, revealed significant deficiencies across its quality systems. Observations included inadequate cleaning and sanitization programs, unvalidated electronic data systems lacking proper controls, and a failure to follow or establish adequate standard operating procedures. Additionally, the firm lacked assurance in cleaning procedure effectiveness, critical utility qualification, equipment qualification, and facility maintenance.