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

An FDA inspection of Neitz Instruments Co., Ltd. in Chiyoda, Tokyo, Japan, a medical device manufacturer, revealed significant deficiencies in its quality system. The firm was cited for inadequate Medical Device Reporting (MDR) procedures, insufficient documentation of corrective and preventive actions (CAPA), and poorly established management review procedures. These observations highlight a need for improved internal controls and adherence to regulatory requirements.