FDA 483 - Neitz Instruments Co., Ltd. - May 19, 2023

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from May 15 to May 19, 2023, Japanese medical device manufacturer Neitz Instruments Co., Ltd., received a Form FDA 483 outlining significant observations. The inspection, carried out under the Federal Food, Drug, and Cosmetic Act, identified three primary issues related to the company's quality system.

Firstly, the company's written procedures for Medical Device Reporting (MDR) were found to be inadequate. Specifically, the internal system lacked a standardized process for evaluating complaints to determine when an event met the criteria for regulatory reporting. Secondly, documentation for corrective and preventive action (CAPA) activities was insufficient, particularly regarding the verification of effectiveness checks. Finally, the procedures for management review were not adequately established, as the firm's Management Review Procedure did not define attendance requirements for these critical meetings.

Neitz Instruments Co., Ltd. is responsible for addressing these observations by conducting thorough internal self-audits to identify and correct all quality system violations. The company is expected to implement prompt corrective actions and can discuss objections or planned actions with the FDA to demonstrate compliance with regulatory requirements.