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

Source: https://www.keypedia.com/records/483/neitz-instruments-co-ltd/3af83dc9-a5fc-4f40-9862-40c0a1da0922

> FDA 483 for Neitz Instruments Co., Ltd. on May 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neitz Instruments Co., Ltd.
- Inspection Date: 2023-05-19
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/neitz-instruments-co-ltd/197bf351-a98e-44d2-b8c7-d15b27b3d70d

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd