The FDA yesterday 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.
Embecta, the BD diabetes business spinoff, manufactures syringe devices for the delivery of insulin. However, the manufacturing for these devices only takes place in the U.S.
Embecta issued a statement reiterating that the FDA notice only applies to plastic syringes made in China. The company manufactures all of its syringes for worldwide distribution at its Holdrege, Nebraska, facility, according to SVP of Global Manufacturing & Supply Chain Shaun Curtis.
“In the coming year, Embecta will mark 100 years since our predecessors developed the world’s first syringe dedicated to insulin delivery, and we are proud of our rich heritage of quality, reliability, and innovation that we have earned in the years since,” Curtis said. “Our skilled workforce in Nebraska, with its unmatched expertise in high volume syringe manufacturing, is prepared to support any healthcare customers who may be affected by the FDA’s safety communication.”
The FDA, meanwhile, plans to collect and analyze data to evaluate the plastic syringes made in China. At the time, the issue does not include glass syringes, pre-filled syringes or syringes used for oral or topical purposes.
“We are concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance,” the agency wrote.
