# FDA 483 - Regent Electron (Suzhou) Co., Ltd. - August 15, 2024

Source: https://www.keypedia.com/records/483/regent-electron-suzhou-co-ltd/e2634904-b194-4cf9-a991-aa5dd1897538

> FDA 483 for Regent Electron (Suzhou) Co., Ltd. on August 15, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Regent Electron (Suzhou) Co., Ltd.
- Inspection Date: 2024-08-15
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Regent Electron (Suzhou) Co., Ltd., a medical device manufacturer, was inspected regarding its watch-style wearable Echocardiograph and Oximeter devices. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate control of non-conforming products, incomplete corrective and preventive action procedures, and poor environmental controls in manufacturing areas. Additionally, issues were noted with record retention, labeling documentation, and finished device acceptance procedures.

## Related Officers

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

Company: https://www.keypedia.com/companies/regent-electron-suzhou-co-ltd/7d0ebc59-2790-4e62-9387-c8c6ae79e5ad

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