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Today, the U.S. Food and Drug Administration (FDA) is providing an update on our ongoing evaluation of quality and performance issues related to plastic syringes made in China. Specifically, the FDA is announcing an import alert for Zhejiang Longde Pharmaceutical Co. Ltd. and Shanghai Kindly Enterprise Development Group Co. Ltd. for not meeting device quality system requirements, to prevent plastic syringes made by these China-based manufacturers from entering the United States.
We are also providing an update to our recommendations:
- Immediately transition away from using plastic syringes manufactured by the following China-based manufacturers, unless use of these syringes is absolutely necessary until you can complete the transition to syringes that are not manufactured in China:
- Jiangsu Caina Medical Co Ltd.
- Jiangsu Shenli Medical Production Co Ltd.
- Shanghai Kindly Enterprise Development Group Co Ltd.
- Zhejiang Longde Pharmaceutical Co Ltd.
We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance, and continue to have recommendations for U.S. suppliers of plastic syringes, consumers, health care providers and facilities. We will continue our efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available.
Questions?
If you have questions about this communication, contact the Division of Industry and Consumer Education.
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