FDA Sends Warning Letters To Chinese Syringe Manufacturer

FDA Sends Warning Letters To Chinese Syringe Manufacturer

August 13th, 2024 // 1:21 pm @

FDA sent warning letters Jiangsu Shenli and Jiangsu Caina in China in July 2024 regardings its practices in manufacturing plastic syringes. In April, the FDA also issued an import alert to both sites.

FDA recently published the warning letters that show the agency conducted an FDA inspection of Jiangsu Shenli and Jiangsu Caina about the time that it named the syringe makers in a plastic syringe investigation. FDA was partially through its inspection of a Jiangsu Caina plant in China when FDA said it was evaluating quality issues and failures of testing performance.

The FDA audit led to the July 2024 warning letters that detailed the firm’s violation of FDA’s quality regulations. Many FDA observations related to how the company produces Monojet syringes, which is a Cardinal Health product that began the FDA investigation into the Chinese-made products in 2023.

The FDA found that Jiangsu Caina looked into a complaint about a syringe that wasn’t compatible with a pump in the summer of 2023. The FDA investigation determined that the syringe was not identified by a Medifusion pump. However, the company didn’t assess all of the reported problems. Nor did it open a CAPA plan.

The warning letter stated that it appeared that Jiangsu Caina didn’t completely analyze and investigate data for complaints for the syringes in question. This may have caused a delay in recognizing the possibility of incompatibility applied to other sizes of Monojet syringes by Cardinal Health.

Also, the July 2024 warning letter to Jiangsu Shenli dealt with other quality system violations. FDA inspectors determined there was no documentation for designing and developing syringes the company sold in the US. FDA also indicated there wasn’t any development and design documentation for the firm’s enternal feeding syringes.


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