The U.S. Food and Drug Administration (FDA) has intensified its scrutiny over the imports of plastic syringes from China due to concerns over their quality. Specifically, during November, the FDA highlighted issues potentially affecting these syringes, including the risk of leaks and breakages. Consequently, the agency advised healthcare providers to opt for syringes produced outside of China where feasible.
In response to these quality concerns, the FDA has taken decisive steps by imposing import bans on several Chinese manufacturers, including Jiangsu Shenli Medical Production, Jiangsu Caina F Medical, Zhejiang Longde Pharmaceutical, and Shanghai Kindly Enterprise Development Group. These actions align with the broader context of the Biden administration’s decision to increase tariffs on various medical products imported from China.
Further emphasizing the agency’s concerns, the FDA issued a warning letter in March to Jiangsu Shenli after discovering the company had been distributing piston syringes of different sizes and configurations that had not been cleared for use by the agency. Additionally, warning letters were sent to U.S. distributors such Si Cardinal Health, Medline Industries, and Sol-Millennium Medical. These companies were notified because they had been selling these unauthorized syringes in the U.S. market.
As a result, companies like Cardinal Health, Medline Industries, and Merit Medical Systems have initiated recalls for the syringes in question to mitigate any risks associated with their use. These measures reflect the FDA’s ongoing efforts to ensure that all medical products used in the U.S., especially critical ones like syringes during medical treatments, meet the necessary safety standards.
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