# FDA 483 - Jiangsu Caina Medical Co., Ltd - July 18, 2025

Source: https://www.keypedia.com/records/483/jiangsu-caina-medical-co-ltd/a549bf82-fd0f-49ea-9767-e673710665ab

> FDA 483 for Jiangsu Caina Medical Co., Ltd on July 18, 2025. 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: 2025-07-18
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Jiangsu Caina Medical Co., Ltd. in Jiangyin City, China, revealed significant deficiencies in their quality system. Observations included inadequate procedures for medical device reporting, corrective and preventive actions, process validation, and procurement control. These issues indicate a lack of robust quality management practices for medical device manufacturing.

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## Related Officers

- [Janete F. Guardia](https://www.keypedia.com/people/janete-f-guardia/2405f83f-7ea9-4056-afbd-7d9c00a6e169)

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

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