FDA 483 - Nippon Shinyaku Co., Ltd. - November 09, 2019

An FDA inspection of Nippon Shinyaku Co., Ltd. in Kyoto, Japan, revealed significant deficiencies in laboratory controls and data integrity practices. Observations included incomplete laboratory records, lack of audit trail review, inadequate computer system controls, and uncontrolled laboratory worksheets. These issues raise concerns about the reliability of data used for clinical studies and regulatory submissions.