FDA suggestion and China syringe
 2024/06/06 | View:169

In light of recent developments regarding the FDA’s investigation of syringes manufactured in China, 

we want to take this opportunity to reaffirm our disposable syringe with unrivaled quality and reliability.


On March 18, 2024, the FDA issued warning letters to multiple manufacturers in China, citing various 

violations. Furthermore, the FDA’s safety communication highlighted that issues with syringes made in 

China are more widespread than previously known, prompting a recommendation for immediate transition away from such products.


The agency first made its worries public late last November, after it collected reports of leaks, breakages 

and other problems. The probe’s scope was limited to imports of standard plastic syringes—glass or 

prefilled syringes, as well as those designed for oral or topical uses, have not been affected.


On 16th May,2024,FDA suggested that Immediately transition away from using plastic syringes 

manufactured by several 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,and 

our company is not in the list.For all other plastic syringes made in China,the FDA’s evaluation 

remains ongoing.


About the problem of potiential syringe failures such as leaks, breakage, and other problems after 

manufacturers made changes to the syringe dimensions,we have solved them.Our syringe are produce 

according to ISO standard.Every production process are checked by several quality inspectors. Also,

there are several inspection equipment ineach machine.Many quality problems are avoided.

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About Us

Changzhou Medical Appliances General Factory Co., Ltd. was built in 1988, it is a modern factory specialized in producing the disposable medical appliances in China. The factory is only 1km to Hengshan entrance of Huning high-speed road and is about 20 miles to Changzhou airport. So the traffic is convenience.
The area of the factory is 40000㎡, the area of purifying workshop is 7000m, and fixed assets are about 5,000,000USD. Our main products are Disposable infusion sets, Disposable blood transfusion sets, Disposable Sterile syringe sets, latex glove, disposable infusion set, simple oxygen mask, nebulizer mask, urine cup, hernia mesh, urine bag etc. Now we can manufacture more than 200,000,000 sets per year.

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