FDA Update

The Safety of Syringes Imported into the US Called into Question As:

The FDA Sends Two Warning Letters after Inspecting Chinese Syringe Manufacturers

The FDA named companies Jiangsu Shenli and Jiangsu Caina as targets of its investigation into the safety of plastic syringes made in China in March. The agency had not completed inspections of either company at that time, but still sent a warning letter to Jiangsu Shenli.  In April, the FDA issued import alerts against both firms.

Now, the FDA has published warning letters that show it inspected Jiangsu Shenli and Jiangsu Caina sites around the time it named the manufacturers in its plastic syringe investigation. The FDA was partway through an inspection of a Jiangsu Caina facility in Jiangsu, China, when they said they were “actively evaluating quality issues and performance testing failures” with the company’s syringes in March.

The inspection resulted in a July 18 warning letter that describes Jiangsu Caina’s violations of the quality system regulation. Many of the FDA’s observations relate to the production of Monoject syringes, the brand of Cardinal Health syringes that triggered the investigation into Chinese products last year.

FDA inspectors found Jiangsu Caina investigated a complaint about the incompatibility of a syringe with a pump in July 2023. The investigation found that the  syringe was not recognized by Medfusion pumps, BUT the company failed to assess all the reported issues or initially open a corrective and preventive action plan.

The July 18 Jiangsu Shenli warning letter also describes other quality system regulation violations. During a visit to Jiangsu Shenli’s facility in Jiangsu, China, in March 2024, FDA inspectors found no documentation related to the design and development of a range of syringes the company exported to the U.S. The FDA also found no design and development documentation for Jiangsu Shenli’s enteral feeding syringes.

Enteral feeding syringes were outside of the scope of the original investigation. The inspection findings led the FDA to add the feeding syringes to the import alert against Jiangsu Shenli and to recommend healthcare providers immediately transition away from using the devices.

You can get to see a copy of the FDA warning letter on the FDA website.

Questions?

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