Today, the U.S. Food and Drug Administration (FDA) has issued an important update regarding the quality and performance issues associated with plastic syringes manufactured in China. This announcement highlights the FDA’s ongoing evaluation and the actions being taken to address potential device failures.
In a significant move, the FDA has announced an import alert for Zhejiang Longde Pharmaceutical Co. Ltd. and Shanghai Kindly Enterprise Development Group Co. Ltd. This alert is due to these manufacturers’ failure to meet the required device quality system standards. As a result, plastic syringes produced by these companies are being prevented from entering the United States to ensure the safety and reliability of medical devices used in the country.
The FDA has also updated its recommendations concerning the use of plastic syringes from certain China-based manufacturers. The key recommendation is to immediately transition away from using plastic syringes produced by the following companies, unless their use is absolutely necessary until a complete transition to alternative syringes is achieved:
- Jiangsu Caina Medical Co Ltd.
- Jiangsu Shenli Medical Production Co Ltd.
- Shanghai Kindly Enterprise Development Group Co Ltd.
- Zhejiang Longde Pharmaceutical Co Ltd.
The FDA’s concern stems from the inconsistent and potentially inadequate quality or performance of these syringes. This ongoing evaluation aims to ensure that all medical devices, especially those as critical as syringes, meet stringent quality standards to protect public health.
The FDA is committed to keeping all stakeholders informed about the progress of this evaluation. This includes U.S. suppliers of plastic syringes, consumers, healthcare providers, and medical facilities. The FDA will continue to monitor and assess the situation, providing updates and additional information as it becomes available.
In summary, the FDA’s actions underscore the importance of maintaining high-quality standards for medical devices and the ongoing efforts to address any potential risks associated with plastic syringes manufactured in China. This proactive approach is crucial for ensuring the safety and efficacy of medical supplies used across the United States.
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