The US Food and Drug Administration (FDA) is providing an update on their ongoing evaluation of quality and performance issues related to plastic syringes made in China, and announcing additional recommendations and actions the FDA is taking to address these issues. 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 US to the following three entities:
- Jiangsu Shenli Medical Production Co. Ltd. (China-based manufacturer of plastic syringes)
- Medline Industries, LP (firm marketing and distributing plastic syringes made in China within the US)
- Sol-Millennium Medical, Inc. (firm marketing and distributing plastic syringes made in China within the US)
