FDA Updates Safety Communication, Sends Letters on Plastic Syringes from China

A Chinese manufacturer and two domestic distributors have received FDA warning letters describing violations related to the sale and distribution of plastic syringes made in China that have not been cleared or approved for sale or distribution in the U.S.

Receiving the letters were China-based manufacturer Jiangsu Shenli Medical Production Co., and Illinois-based distributors Medline Industries and Sol-Millennium Medical. The warning letters for Medline Industries and Sol-Millennium Medical also include violations related to quality system regulations for syringe products.

In November 2023, the FDA issued a Safety Communication warning of leaks, breakage and other problems with plastic syringes made in China and urged users to check the manufacturing location of syringes and not use them while the agency considers preventing syringes made in China from entering the U.S.

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