# FDA 483 - Jiangyin SINBON Electronics Co., Ltd. - April 17, 2025

Source: https://www.globalkeysolutions.net/records/483/jiangyin-sinbon-electronics-co-ltd/4a2c0255-1b1e-4709-a64e-b39b9a07a7e3

> FDA 483 for Jiangyin SINBON Electronics Co., Ltd. on April 17, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangyin SINBON Electronics Co., Ltd.
- Inspection Date: 2025-04-17
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Jiangyin SINBON Electronics Co., Ltd. in Wuxi, China, a contract manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for design change, corrective and preventive actions, and control of nonconforming products. These issues indicate a lack of robust quality management practices.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.globalkeysolutions.net/companies/jiangyin-sinbon-electronics-co-ltd/9d9fc4c1-c481-4115-aeda-b2fb2ec067d5

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8