FDA 483 - Tokyo Chemical Industry Co Ltd - October 19, 2018

On October 15-19, 2018, the U.S. Food and Drug Administration (FDA) inspected Tokyo Chemical Industry Co., Ltd. in Fukaya, Saitama, Japan, an Active Pharmaceutical Ingredients manufacturer. The inspection resulted in a Form FDA 483, detailing significant observations related to the company's manufacturing and quality control systems, indicating potential deviations from Good Manufacturing Practices.

Key observations included failures within the laboratory system. Specifically, the firm's test procedures for identifying raw materials and Active Pharmaceutical Ingredients (APIs) were found not to be scientifically sound. For instance, Infrared Spectroscopy identification tests used reference standard spectra that were not generated concurrently with samples, nor were they regularly reviewed or updated. Additionally, there was a lack of documentation for High Performance Liquid Chromatography (HPLC) standard injections. A critical data integrity issue was also noted, as computer systems controlling HPLC and Gas Chromatography (GC) lacked appropriate controls, allowing for the deletion of electronic raw data without quality assurance or quality control oversight.

Furthermore, observations extended to the material system. The company's procedure for handling returned products did not ensure analytical testing for materials whose storage conditions were uncontrolled or unknown before redistribution, even if packaging was intact and within expiry dates. Tokyo Chemical Industry Co., Ltd. is required to address these observations by implementing comprehensive corrective actions to ensure compliance with regulatory standards for pharmaceutical manufacturing.