Becton, Dickinson and Company (BD) has announced its intention to increase US production of syringes after FDA recently reported that its ongoing investigation into quality issues with plastic syringes made in China were “more widespread” than originally known.

FDA initially issued a safety communication informing consumers of potential device failure with plastic syringes manufactured in China late last year. At the time, the agency did not name any specific companies, but, according to previous MD+DI reporting, said it had “received information about quality issues associated with several Chinese manufacturers of plastic syringes including leaks, breakage, and other problems and recommended that consumers, healthcare providers, and facilities not use syringes manufactured in the country if possible.”

This sparked speculation of the potential companies involved in the communication. Of note, the late 2023 notice came only two weeks after the agency issued a Class I recall to both Cardinal Health and Fresenius Medical Care in relation to disposable syringes, listing similar quality issues noted in the safety communication, such as leaks and changes to syringe dimensions.

In response to the speculation, multiple companies also started sharing statements reiterating that the FDA warning did not impact their products as they are not manufactured in China. Embecta, BD’s diabetes business spinoff, was one such company to clarify its manufacturing location, writing in a statement that it manufactures all of its syringes for worldwide distribution at its Holdrege, Nebraska, facility.

Months since the safety communication, FDA recently published an update to its investigation into syringe quality issues, writing it had conducted facility inspections for Medline Industries, and Sol-Millenium Medical, detained and examined products at the border, and done lab tests on the syringes.

On March 18, the agency issued warning letters to three companies: Jiangsu Shenli Medical Production — a China-based manufacturer of plastic syringes, Medline, and Sol-Millenium Medical — which market and distribute those plastic syringes within the US.

The warning letters described violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by FDA for use in the US. Additionally, in its warning letter to Medline, FDA said it is also evaluating quality and performance issues related to plastic syringes made by China-based Jiagngsu Caina Medical, citing “unexpected and unexplained failures” seen in several plastic syringes.

In a statement from Sol-Millenium, the company said it is working with FDA to resolve the issues and highlighted that it does not have relationships with Jiangsu Caina Medical and Jiangsu Shenli Medical Production and its products are not manufactured by either company.

“Since November 2023, Sol-Millennium has been providing reports of actions it has taken to address any findings identified in the Warning Letter. These are regulatory in nature,” according to the company statement. “Since September 2023, the FDA has inspected approximately one third of Sol-Millennium’s inbound shipments into the United States, including multiple lab tests, and has had zero quality concerns. Sol-Millennium has no relationship with Jiangsu Caina Medical Co Ltd, and Jiangsu Shenli Medical Production Co Ltd. No Sol-Millennium products are manufactured by either company.”

The agency also reiterated its recommendation to transition away from plastic syringes made in China, specifically naming Jiangsu Caina Medical and Jiangsu Shenli Medical Production.

BD has responded to this latest update from FDA by further increasing its domestic manufacturing of syringes at the company’s Nebraska and Connecticut facilities. The company initially upped its manufacturing after the 2023 safety communication, writing in its statement clarifying its manufacturing location that “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.”

Eric Borin, president of BD Medication Delivery Solutions, said in the recent statement that the company decided to increase US production to ensure continuity of patient care.

“Ensuring the safety and quality of our products is the top priority at BD. The latest FDA safety communication does not include any BD syringes. 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.”

Article Source:MDDI