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

Central Glass Co., Ltd. in Ube, Japan, an API manufacturer, was cited for six observations during an FDA inspection from September 11-15, 2023. The inspection revealed significant deficiencies in laboratory controls, water specifications, cleaning validation, change control, process validation, and raw material receiving procedures. These issues indicate a lack of robust quality systems and control over critical manufacturing processes.