Dive Brief:
- The Food and Drug Administration published an expanded import alert Wednesday to stop all plastic syringes made by a Chinese manufacturer from entering the U.S.
- On March 28, the FDA issued an import alert to stop the company, Jiangsu Shenli Medical Production, from importing only unauthorized plastic syringes into the U.S. The agency expanded the blockade this week to all plastic syringe models because the company failed to meet device quality system requirements.
- The expanded import alert is the latest in a series of FDA actions in response to reports that plastic syringes made in China can leak, break and otherwise suffer quality problems.
Dive Insight:
The FDA imposes import alerts to allow it to detain products without a physical examination. The agency uses the power when an inspection has found a company is breaching good manufacturing practices or if a foreign regulator has shared details of similar problems with the FDA.
The agency sent a warning letter to Jiangsu Shenli in March after inspecting Medline Industries, a company that distributes its plastic syringes in the U.S. FDA inspectors accused Medline of providing Jiangsu Shenli devices that have substantially different technological characteristics than the device authorized in the Chinese company’s 510(k) clearance.
At that time, the FDA advised healthcare providers to immediately move away from using unauthorized plastic syringes produced by Jiangsu Shenli unless absolutely necessary. The company’s only authorized device is a 5 mL luer lock syringe. Later, the FDA issued an import alert against Jiangsu Shenli but limited the scope of the ban to the unauthorized devices it targeted in the warning letter.
On Wednesday, the FDA expanded its import alert and recommendation against using Jiangsu Shenli devices to cover all the company’s plastic syringes. The agency said it expanded the alert “for not meeting device quality system requirements.”
The update means the FDA now has import alerts in place against all the products from both Chinese companies targeted in the investigation to date. The FDA issued an import alert against the other plastic syringe manufacturer, Jiangsu Caina Medical, on April 3.