BD (NYSE:BDX) announced today that it is increasing its U.S. syringe production after the FDA issued warnings related to syringes manufactured in China.
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.
Earlier this week, the agency issued warning letters to three companies, including U.S.-based Medline. The 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 sale or distribution in the U.S.
In response to the latest developments, President of BD Medication Delivery Solutions, Eric Borin, issued a statement today. In that statement, Borin said BD has the capacity to support additional syringe demand.
As a result, the company decided to increase U.S. production to ensure continuity of patient care. The company already increased manufacturing at Nebraska and Connecticut facilities following the initial FDA communication in November.
Borin added that the latest FDA communication does not include any BD syringes.
“Ensuring the safety and quality of our products is the top priority at BD,” Borin said. “Over our more than 125-year history, we have served the health care system’s need for essential high quality medical products, including manufacturing 2 billion additional syringes and needles to support the global pandemic response to COVID-19.
“BD remains committed to supporting the health care system and patients, and our clinical staff are prepared to support customers with any questions they may have regarding our products.”