FDA 483 - Central Glass Co., Ltd. - September 11, 2023

Central Glass Co., Ltd., an API manufacturer in Ube, Yamaguchi, Japan, received six observations during an FDA inspection from September 11-15, 2023. The inspection revealed significant deficiencies across multiple areas, including inadequate laboratory controls, unsuitable water specifications, unvalidated cleaning procedures, and a lack of formal change control for critical changes. These findings indicate a need for improved quality systems and process control.