FDA 483 - Meiji Seika Pharma Co., Ltd. - Gifu Plant - September 02, 2022

Meiji Seika Pharma Co., Ltd. in Gifu, an API manufacturer, was cited with three observations during an FDA inspection. The inspection revealed issues with the independence of the quality unit, inadequate controls over computerized label printing systems, and poor facility maintenance including water damage and mold in a raw material warehouse. These findings indicate significant deficiencies in quality systems and facility controls.