The U.S. Food and Drug Administration (FDA) has intensified its scrutiny of plastic syringes manufactured in China, issuing three warning letters to entities involved in their sale and distribution within the United States. These letters, dated March 18, 2024, were directed to Jiangsu Shenli Medical Production Co. Ltd., Medline Industries, LP, and Sol-Millennium Medical, Inc., outlining violations related to the unauthorized sale and distribution of plastic syringes not cleared or approved by the FDA for use in the U.S. The FDA also raised concerns about violations of quality system regulations pertaining to syringe products, particularly in the cases of Medline Industries, LP, and Sol-Millennium Medical, Inc.
The FDA’s actions were prompted by an ongoing evaluation of quality and performance issues associated with plastic syringes manufactured in China. This evaluation began in November 2023 when the FDA first alerted consumers and healthcare providers about potential device failures linked to these syringes, such as leaks and breakage. The FDA’s focus is solely on plastic syringes, with glass syringes, pre-filled syringes, and syringes for oral or topical use not implicated in the probe. The warning letters emphasize the need for immediate action from the recipients to address the identified violations. The FDA has urged healthcare professionals and facilities to transition away from using plastic syringes made by Jiangsu Caina Medical Co Ltd and unauthorized plastic syringes manufactured by Jiangsu Shenli Medical Production Co Ltd until alternative options can be implemented. For other plastic syringes made in China, the FDA recommends careful monitoring for defects while transitioning to non-China-made alternatives where possible.
The FDA’s concern extends beyond the specific entities addressed in the warning letters. The agency is actively investigating quality issues and performance testing failures associated with other Chinese manufacturers, such as Jiangsu Caina Medical Co Ltd, to address potential risks associated with plastic syringes made in China. This approach includes facility inspections, product testing, and collaboration with stakeholders to ensure the safety and reliability of syringes used in healthcare settings across the U.S.. In light of these developments, healthcare providers, consumers, and suppliers are urged to remain vigilant and report any issues with syringes to the FDA through the MedWatch Voluntary Reporting Form. Healthcare facilities subject to FDA’s user facility reporting requirements should follow established reporting procedures. By actively engaging with stakeholders and continuing to evaluate problems associated with syringes made in China, the FDA aims to mitigate risks and safeguard public health while maintaining the integrity of the medical device supply chain.
The FDA’s evaluation process has revealed complexities regarding the quality and safety of plastic syringes manufactured in China. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, noted that further assessment of safety concerns has indicated that quality problems are more widespread than initially understood. The FDA is actively evaluating quality issues and performance testing failures at another Chinese manufacturer, highlighting the complexity of ensuring the safety and efficacy of medical devices sourced from global manufacturers. The warning letters sent by the FDA highlight specific violations related to the sale and distribution of unauthorized plastic syringes made in China. Inspections conducted at U.S. sites run by Medline Industries and Sol-Millennium Medical revealed breaches of quality system regulations and unauthorized marketing of syringe products. These violations outline the importance of strict regulatory oversight to uphold safety standards and protect public health in the medical device industry.
The FDA’s commitment to thorough assessment and regulatory action outlines its dedication to ensuring the safety and efficacy of medical devices used in healthcare settings across the United States. By addressing quality issues and implementing appropriate corrective actions, the FDA aims to mitigate risks associated with plastic syringes made in China and maintain the integrity of the medical device supply chain. Healthcare providers, consumers, and suppliers play an important role in promoting patient safety by remaining vigilant and reporting any issues with syringes to the FDA. Through transparent communication and collaboration with stakeholders, the FDA aims to address concerns related to plastic syringes manufactured in China and uphold the highest standards of safety and quality in the healthcare industry.