FDA Concerns Prompt Action
In response to FDA concerns over the quality of China-made syringes, Becton Dickinson And Co (BDX) announced an escalation in U.S. syringe output. The FDA advised against the use of selected Chinese syringes due to ongoing quality investigations.
Boosting US Production
BD Medication Delivery Solutions President, Eric Borin, assured, “BD has the capacity and is escalating U.S. production to meet rising syringe demand. Following the FDA’s safety alert in November, BD has bolstered syringe manufacturing in Nebraska and Connecticut to meet customer requirements.”
Quality Concerns Unearthed
The FDA’s November 2023 announcement alerted consumers and healthcare bodies to potential issues with plastic syringes manufactured in China. Concerns include device failures such as leaks and breakages, sparking an evaluation of syringe quality from Chinese manufacturers.
Violation Citations
Three Chinese companies – Jiangsu Shenli Medical Production Co. Ltd, Medline Industries LP, and Sol-Millennium Medical Inc. – faced regulatory citations for syringe manufacturing violations. The FDA expressed ongoing unease regarding the consistency and performance of Chinese-made syringes.
Robust FDA Investigation
An extensive review by CNBC revealed over 4,000 reports of plastic syringe issues in 2023, though not limited to China. The FDA acknowledged data limitations due to incomplete information and potential under-reporting, emphasizing the gravity of their probe.
As of Thursday’s close, BDX shares were up 1.18% at $240.68. The market’s reaction underscores investor confidence in Becton Dickinson’s responsiveness to regulatory concerns and commitment to patient care.
Illustration of Pharma lab worker created with MidJourney.
