FDA 483 - Fujimoto Chemicals Co., Ltd., Kinraku Plant - February 01, 2024

An FDA inspection of Fujimoto Chemicals Co., Ltd., Kinraku Plant in Hyogo, Japan, a manufacturer of drug substances, revealed significant deficiencies in their quality control systems. Observations included inadequate laboratory test procedures for related substances and microbiological examination, a risk of contamination in the water system due to dead legs, and a failure to visually examine reserve samples for deterioration. These findings indicate a need for comprehensive improvements in their manufacturing and control processes.