# FDA 483 - The Yoshida Dental Manufacturing Co., Ltd. - April 14, 2023

Source: https://www.globalkeysolutions.net/records/483/the-yoshida-dental-manufacturing-co-ltd/8f140e9f-f434-4f22-9e65-ef6abce1efa6

> FDA 483 for The Yoshida Dental Manufacturing Co., Ltd. on April 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Yoshida Dental Manufacturing Co., Ltd.
- Inspection Date: 2023-04-14
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: The Yoshida Dental Manufacturing Co., Ltd. in Sumida-Ku, Tokyo, a medical device and electronic product manufacturer, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures and implementation for corrective and preventive actions, medical device reporting, design input, design output, and design validation. These issues indicate a systemic lack of control over critical aspects of device design and quality management.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/the-yoshida-dental-manufacturing-co-ltd/22ee419b-0310-45c6-b4b6-85674f40a2e9

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