FDA 483 - Intelligent System Co., Ltd. - May 18, 2023

An FDA inspection conducted at Intelligent System Co., Ltd. in Nanto, Toyama, Japan, from May 15-18, 2023, identified significant deficiencies in the company's quality system. The firm, a specification developer and manufacturer, received a Form FDA 483 outlining three primary observations.Firstly, the company lacked adequate written procedures for servicing activities. This included failures to properly document service reports, verify that service met device specifications, process device malfunctions requiring repair as formal complaints, and statistically analyze service data. Secondly, the inspection revealed a failure to establish sufficient procedures for receiving, reviewing, and evaluating customer complaints through a formally designated unit. Finally, Intelligent System Co., Ltd. was cited for not developing, maintaining, and implementing written procedures for Medical Device Reporting (MDR).These observations indicate non-compliance with fundamental quality system requirements for medical device manufacturers, enforced by the FDA under the Federal Food, Drug, and Cosmetic Act. In response to the inspection, Intelligent System Co., Ltd. committed to correcting all identified issues. This requires the immediate development and implementation of robust, compliant procedures for device servicing, complaint handling, and medical device reporting to ensure product safety and regulatory adherence.