BD boosts US production as FDA warns against using plastic syringes from China

The FDA last week re-upped its recommendations that healthcare providers avoid using plastic syringes made in China wherever possible, while it continues to investigate growing quality concerns. In response, BD said it would be increasing U.S. production of the ubiquitous drug delivery hardware to help cover the gap.

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.

However, the FDA said that facility inspections, as well as examining incoming products at the border and in the laboratory, have led it to elevate the issue.

“Our ongoing evaluation has confirmed that issues with the quality of plastic syringes made in China and their distribution in the U.S. are more widespread than originally known,” the FDA’s device center director, Jeff Shuren, M.D., said in an update last week.

As a result, the agency said it had issued a trio of warning letters on March 18—including one to the China-based syringe maker Jiangsu Shenli Medical Production Co. Ltd.—as well as to the U.S.-based Medline and Sol-Millennium, which also market plastic syringes made in China, albeit some from other manufacturers.

“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.,” Shuren said. “The warning letters for Medline Industries, LP and Sol-Millennium Medical, Inc. also concern violations related to quality system regulations for syringe products.”

The agency said that providers should “immediately transition away” from nearly all models of plastic syringes manufactured by Jiangsu Shenli, as well as those from Jiangsu Caina Medical Co. Ltd., unless they are absolutely necessary—with the agency doubting their ability to deliver correct doses either alone or when paired with an infusion pump.

In a statement in response, Sol-Millennium said it has no commercial relationship with or has any products manufactured by Jiangsu Shenli or Jiangsu Caina—and that “after multiple communications with the FDA, we are confident that all the issues can be resolved.”

The company’s warning letter in part focuses on its marketing of a syringe shipped with a needle attached—two products that have their own 510(k) clearances separately but have not been greenlit as a combined unit. Sol-Millennium said it is in the process of submitting a new regulatory application.

Medline’s letter, meanwhile, said that while the company had received a 510(k) for a single version of a luer lock-equipped, 5-cc piston syringe made by Jiangsu Shenli, additional clearances would be needed for its different sizes, colors and other changes in its hardware. The letter to Jiangsu Shenli airs many of the same concerns.

“The FDA believes that the supply and manufacturing capacity of plastic syringes made in countries other than China, including domestic manufacturing, is adequate to support current health care demand. Therefore, the agency does not anticipate that a shift in the supply chain is likely to lead to a shortage of these products,” Shuren said. 

At BD, the company said it has been increasing its production at sites in Nebraska and Connecticut since the FDA’s initial November missive.

“BD has the capacity to support additional syringe demand and is further increasing U.S. production to help ensure continuity of patient care,” said BD Medication Delivery Solutions President Eric Borin. “Over our more than 125-year history, we have served the health care system's need for essential high-quality medical products, including manufacturing 2 billion additional syringes and needles to support the global pandemic response to COVID-19.”