# Beijing Kingst Commercial & Trade Co., Ltd. – FDA 483, Apr 25, 2024

Source: https://www.keypedia.com/records/483/beijing-kingst-commercial-trade-co-ltd/a8f32bc9-eb4b-4aae-867e-d01600720305

> FDA 483 for Beijing Kingst Commercial & Trade Co., Ltd. on April 25, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Beijing Kingst Commercial & Trade Co., Ltd.
- Inspection Date: 2024-04-25
- Product Type: device
- Office Name: Division of Blood Components and Devices
- Summary: An FDA inspection of Beijing Kingst Commercial & Trade Co. Ltd., a medical device manufacturer in Beijing, China, revealed a significant deficiency in their quality system. The firm failed to adequately establish process control procedures for soldering operations during the assembly of Class II medical devices, specifically lacking clear descriptions and parameters to ensure product specifications are met.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/beijing-kingst-commercial-trade-co-ltd/1bf18ec9-1e01-4823-8d79-261a16618556

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917