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# Import Alert Against China Syringe Maker
- URL: https://www.fdaweb.com/import-alert-against-china-syringe-maker/
- Published: 2024-04-10T12:00:00.000Z
- Updated: 2026-09-14T14:27:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156753

In the latest move by FDA in its ongoing investigation into the quality of syringes made in China, the agency is [announcing](https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication?utm%5Fmedium=email&utm%5Fsource=govdelivery) expanded actions against Jiangsu Shenli Medical Production Co. Ltd. with an additional [import alert](https://cms.fda.gov/vts/imports%5Fpublish/private/importalert%5F241.html?ref=fdaweb.com) for not meeting device quality system requirements. The import alert is intended to prevent all plastic syringes distributed by this manufacturer from entering the U.S.

FDA began its investigation late last year, which is described in a related [safety communication](https://public4.pagefreezer.com/browse/FDA/13-03-2024T15:34/https:/www.fda.gov/medical-devices/safety-communications/evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication?ref=fdaweb.com), on potential device failures with certain plastic syringes made in China. “The FDA previously received information about concerns with the performance and safety of these syringes, including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps,” the agency says.

Last month, FDA issued three Warning Letters to Jiangsu Shenli Medical Production Co. Ltd, Medline Industries and Sol-Millennium Medical. “All three Warning Letters describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for use in the U.S.,” an [FDA release](https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-provides-update-plastic-syringes-made-china-issues-warning-letters-related-violative-products?utm%5Fmedium=email&utm%5Fsource=govdelivery) said at the time.