On Wednesday, the FDA issued an additional warning letter that describes 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. The warning letter issued to Cardinal Health (firm marketing and distributing plastic syringes made in China within the U.S.) also describes violations related to quality system regulations for syringe products. The FDA expects this firm to fully address the violations described in the warning letter. The FDA will continue efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available.