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FDA blacklists two new China-based syringe manufacturing companies

The FDA added two new China-based companies to its list of syringe manufacturers that can no longer import products to the U.S.

In an alert dated May 16, the FDA said Zhejiang Longde Pharmaceutical Co. and Shanghai Kindly Enterprise Development Group Co. failed to meet device quality system requirements. As a result, the two join a list of China-based manufacturers whose plastic syringes can’t enter the U.S.

In November 2023, the FDA warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality issues associated with several Chinese syringe manufacturers.

On March 18, 2024, the FDA issued warning letters that 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 sale or distribution in the U.S. to three companies: Jiangsu Shenli Medical Production, Medline Industries and Sol-Millenium Medical. Now, Zhejiang Longde and Shanghai Kindly join the trio. Meanwhile, BD in March announced efforts to step up domestic production in response to the import bans on those syringes.

The FDA updated its recommendations for users to immediately transition away from using plastic syringes made by those companies. Drug Delivery Business

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