The FDA followed up on a 2023 warning letter over unauthorized plastic syringes by issuing a warning letter to Medline.
In November, 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.
Medline — the fourth-largest medical device company in the world, according to our 2023 Big 100 list — markets and distributes plastic syringes made in China within the U.S.
Outlining the alleged FDA violations at Medline
The FDA’s warning letter identified violations related to quality system regulations for syringe products. The FDA expects the companies, including Medline to fully address the violations described in the warning letters.
According to the letter, the FDA carried out an investigation of Medline’s Northfield, Illinois, facility between Dec. 11, 2023, and Jan. 22, 2024. The letter alleges that multiple syringes are adulterated because Medline and Jiangsu Shenli do not have an approved application for premarket approval (PMA) or an approved application for an investigational device exemption (IDE). The FDA also says the company misbranded the devices by not notifying the agency of its intent to introduce the devices into commercial distribution.
Additionally, the FDA identified quality issues that could lead to “serious patient harm.” Its investigation revealed “multiple customer complaints regarding quality issues.” That includes cracks and breakage during use for the syringes in the Medline surgical kits. It includes syringes supplied by Jiangsu that Medline failed to properly investigate, the FDA said.
According to the FDA, a response from Medline dated Feb. 12, 2024, proved inadequate.
“Your firm’s failure to ensure the syringes you are including in convenience kits, importing, and commercially distributing in the United States have 510(k) clearance has prevented FDA from evaluating the risks posed by these substantially different technological characteristics or from determining that there is reasonable assurance of the safety and effectiveness of these modified devices such that they may be legally marketed syringes,” the FDA wrote.
