# FDA 483 - Jiangsu Caina Medical Co., Ltd - March 23, 2024

Source: https://www.globalkeysolutions.net/records/483/jiangsu-caina-medical-co-ltd/a44b4649-a9a6-4c5b-a4d6-b45fd0534c32

> FDA 483 for Jiangsu Caina Medical Co., Ltd on March 23, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu Caina Medical Co., Ltd
- Inspection Date: 2024-03-23
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: The FDA inspection of JIANGSU CAINA MEDICAL CO., LTD in Jiangyin, China, revealed significant quality system deficiencies for medical devices intended for the US market. The firm failed to submit required MDR reports, lacked adequate corrective and preventive action procedures, and had insufficient risk analysis. Additionally, issues included poor control of nonconforming products, improper identification of product acceptance status, and inadequate device history records, compounded by personnel unfamiliar with US FDA regulations.

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## Related Officers

- [Felix J. Marrero](https://www.globalkeysolutions.net/people/felix-j-marrero/fe3bf64e-987b-40d9-8a17-754d58e13433)

Company: https://www.globalkeysolutions.net/companies/jiangsu-caina-medical-co-ltd/9508f928-7299-4175-b273-f198c7427225

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