The FDA is announcing an import alert for Zhejiang Longde Pharmaceutical Co. Ltd. and Shanghai Kindly Enterprise Development Group Co. Ltd. for not meeting device quality system requirements, to prevent plastic syringes made by these China-based manufacturers from entering the United States.
The FDA recommendations have been updated to include that users should also immediately transition away from using plastic syringes made by these manufacturers, unless use of these syringes is absolutely necessary until the transition to syringes that are not manufactured in China is complete.
In March, the FDA provided an update on its ongoing evaluation of quality and performance issues related to plastic syringes made in China, and announced additional recommendations and actions it's is taking to address these issues.
In November 2023, the FDA informed consumers, health care providers, and health care facilities that the FDA is evaluating the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China, that are used for injecting fluids into, or withdrawing fluids from, the body. We had received information about quality issues associated with several China-based manufacturers of syringes. The issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.
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 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 U.S.)
- Sol-Millennium Medical, Inc. (firm marketing and distributing plastic syringes made in China within the U.S.)
The warning letters for Medline Industries, LP and Sol-Millennium Medical, Inc. also concern violations related to quality system regulations for syringe products. The FDA said it expects these entities to fully address the violations described in the warning letters. In addition, we are actively evaluating quality issues and performance testing failures with plastic syringes made by Jiangsu Caina Medical Co Ltd, a China-based manufacturer cited in the warning letter issued to Medline Industries, LP. The FDA will take additional steps as appropriate.
