Astellas Pharma Inc. – FDA 483, Oct 7, 2019

An FDA inspection of Astellas Pharma Tech Co. Ltd. in Toyama-Shi, Japan, a drug substance intermediate manufacturer, revealed significant deficiencies in their quality control systems. Observations included a failure to follow written procedures for documenting the use of critical equipment, specifically the absence of required log books for freezers. Additionally, the firm's procedural controls for handling and documenting in-process samples were found to be inadequate, leading to unlabeled samples and process materials.