FDA 483 - Sumitomo Chemical Co., Ltd. - September 20, 2016

An FDA inspection of Sumitomo Chemical Co., Ltd. in Anpachi-cho, Gifu, Japan, an API manufacturer, revealed significant deficiencies in laboratory controls and document management. The firm failed to conduct proper investigations into unexplained laboratory discrepancies and did not retain raw data calculations. Additionally, the Quality unit exhibited inadequate control over the issuance of master production records.