FDA 483 - AGC, Inc. - October 27, 2023

AGC Inc. in Ichihara-shi, Chiba, Japan, an API manufacturer, received a Form FDA 483 with three observations. The inspection revealed significant issues with the firm's quality unit, including inadequate analytical procedures, sampling, and specifications for raw materials and finished APIs. Additionally, the firm failed to adequately investigate deviations related to environmental monitoring and out-of-specification results, and lacked proper control over its label storage and printing system.