FDA official: Chinese plastic syringe issues emblematic of larger manufacturing concerns

Updated 7 August 2024 with clarification about OSCR's current funding status.

Amid ongoing concerns about Chinese-made plastic syringes, a top US Food and Drug Administration (FDA) official said the agency’s worries extend beyond syringes.

In an interview with Focus, Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation at the Center for Devices and Radiological Health (CDRH), expressed concern that some Chinese manufacturers are not following the agency's quality system requirements and said the agency’s limited resources make it hard to ensure all the products on the market are up to par.

In recent months, FDA has issued several safety alerts warning health care practitioners and consumers not to use Chinese-made plastic syringes unless there are no other options. The agency has also sent warning letters to multiple manufacturers, and several companies have issued recalls for the affected products.

However, Schwarz said the issue goes beyond syringes. She noted that while the agency started getting MedWatch reports from healthcare providers about Chinese-made syringes last summer, it has been tracking the problem with Chinese-manufactured products in other areas for a long time.

“Outside of syringes, we've seen concerns with regard to substandard quality products coming from China in other product areas, even during the pandemic,” said Schwartz. “Given the constrained resources that the agency has, it's not as though we're in a position to be able to conduct the kind of on-site inspections of facilities to determine whether or for how long these issues have existed.

“From everything that we have seen, we understand it to be a much more pervasive and systemic issue that simply just hasn't occurred all of a sudden in the past year but has been ongoing for quite some time,” she added.

Schwartz noted that in the past several years, plastic syringe manufacturing has significantly shifted from the US to foreign manufacturers, with China becoming the dominant foreign manufacturer in this space. As a result, FDA has shifted resources to inspect syringes made in China, which has revealed the problems with some manufacturers failing to follow good manufacturing practices (GMP).

“It's a cost issue in terms of production, manufacturing, and labor,” said Schwartz. “US domestic manufacturers really cannot compete with products coming in from China.”

Schwartz said that while there isn't enough information on whether the pandemic had anything to do with Chinese-manufactured products failing to meet regulatory expectations, she noted that FDA started seeing issues with manufacturers failing to conform to quality systems requirements during the pandemic. In particular, she noted CDRH became very concerned when a significant number of Chinese-made respirators did not meet its regulatory expectations, and the agency had to revoke their emergency use authorization (EUA).

According to Schwartz, the big lesson from the ongoing issues with Chinese-made products is that FDA needs to adequately resource its Office of Supply Chain Resilience (OSCR). The resources the office has received from congressional appropriations have allowed it to partner with industry and mitigate potential product shortages, or at least see them coming before they happen, and has allowed the agency to state that it doesn’t see a shortage of plastic syringes due to the manufacturing issues in China that it has pinpointed.

However, Schwartz also noted that COVID-19 supplemental funds for OSCR will dry up over the next year, leading FDA to fold some of its capabilities over the next several months. She added that while FDA is very appreciative of its current base level of appropriations, these funds are not adequate to sustain OSCR's current work once the supplemental funds run out.

FDA's ask of Congress has been to assure an appropriations funding level to enable OSCR's operations to be maintained and avoid putting the agency in an untenable and precarious position where it won't be able to address many product shortage issues.

For now, Schwartz said FDA is taking every opportunity it can to explain to key stakeholders on the Hill how important it is for the agency to receive the funding it needs to ensure products coming to the US meet its quality system requirements and to ward off potential product shortages.

Another big lesson from this experience, according to Schwartz, is that FDA heavily relies on healthcare providers and consumers to voluntarily alert the agency about product shortcomings, and she encourages stakeholders to keep submitting reports when they come across subpar products.

“This just shows how important it is for those who actually are holding the syringes in their hands and using them to provide information back to CDRH when they encounter problems with the performance of a device,” said Schwarz. “It's by being able to gather and assimilate that data to further synthesize and analyze it that we can identify issues that allow us then to put appropriate steps in place to prevent harm from occurring.”

FDA official: Chinese plastic syringe issues emblematic of larger manufacturing concerns

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