# FDA 483 - MD Instruments Mfg. Co., Ltd. - April 13, 2023

Source: https://www.globalkeysolutions.net/records/483/md-instruments-mfg-co-ltd/822a9fe0-e704-4c37-95de-8cc4e6867280

> FDA 483 for MD Instruments Mfg. Co., Ltd. on April 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MD Instruments Mfg. Co., Ltd.
- Inspection Date: 2023-04-13
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: MD Instruments Mfg. Co., Ltd. in Inashiki-gun, Ibaraki, Japan, was inspected regarding its manufacturing of medical devices and electronic products. The inspection revealed significant deficiencies in establishing and maintaining records related to electronic product radiation safety tests for their diagnostic X-ray systems. These issues indicate a lack of proper documentation for test methods, devices, and procedures.

## Related Officers

- [Joshua J. Silvestri](https://www.globalkeysolutions.net/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.globalkeysolutions.net/companies/md-instruments-mfg-co-ltd/ad33c85d-5dcd-4758-b3cc-bd023a964247

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