FDA Warning Letters on Chinese Syringes
FDA has issued Warning Letters (see below) to Jiangsu Shenli Medical Production Co. Ltd, a China-based plastic syringe manufacturer, and Medline Industries and Sol-Millennium Medical, two firms marketing and distributing in the U.S. plastic syringes made in China. “All three Warning Letters 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 use in the U.S.,” an FDA release says. The latter two letters also concern violations of quality system regulations for syringe products, and the agency says it expects the firms to “fully address the violations” described in them.
The letters are the latest action from FDA’s investigation that began late last year, which is described in a related safety communication, on potential device failures with certain plastic syringes made in China. “The FDA previously received information about concerns with the performance and safety of these syringes, including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps,” the agency says.
View the Warning Letters here: