FDA 483 - Tokyo Chemical Industry Co Ltd - October 15, 2018

An FDA inspection of Tokyo Chemical Industry Co., Ltd in Fukaya, Saitama, Japan, an Active Pharmaceutical Ingredients manufacturer, revealed significant deficiencies. Observations included failures in ensuring scientifically sound test procedures for raw materials and APIs, inadequate controls over laboratory computer systems to prevent data deletion, and insufficient procedures for handling returned products. These issues indicate a lack of robust quality control and data integrity practices.