Syringe safety has come under scrutiny as the Food and Drug Administration (FDA) issued two additional warning letters related to plastic syringes manufactured in China. One of these letters concerns the production of plastic syringes for Cardinal Health. The FDA announced these actions on Thursday, following inspections of facilities operated by Jiangsu Shenli Medical Production and Jiangsu Caina Medical in China. These measures are part of the FDA’s ongoing efforts to ensure the safety and quality of medical devices entering the U.S. market.
Jiangsu Shenli Medical Production received its second FDA warning letter, following one issued in March, due to continued concerns about its production practices. The FDA has expanded the import alert against the company to prevent enteral syringes from entering the U.S. market. This decision follows an inspection that revealed significant issues in the company’s quality management system.
Syringe Quality Concerns: Jiangsu Caina Medical Issued FDA Warning Letter for Multiple Regulatory Violations
Jiangsu Caina Medical was also issued a warning letter after an inspection of its facility revealed multiple violations of quality system regulations. Jiangsu Caina was already under an import alert prior to this inspection. The FDA’s inspection at Jiangsu Caina’s facility in March identified ongoing quality issues and performance testing failures related to their syringes.
The FDA had initially targeted Jiangsu Shenli and Jiangsu Caina in March as part of an investigation into the safety of plastic syringes manufactured in China. Although the agency had not completed inspections at that time, it had issued a warning letter to Jiangsu Shenli and import alerts against both companies by April. The recent inspections provided additional evidence of regulatory violations at both companies.
During the inspection of Jiangsu Caina, FDA inspectors identified significant quality system regulation violations, particularly concerning the production of Monoject syringes—a brand of Cardinal Health syringes that prompted the FDA’s investigation into Chinese-manufactured syringes last year. The inspection revealed that Jiangsu Caina had failed to properly investigate a complaint from July 2023 about the incompatibility of a syringe with a Medfusion pump. The company did not thoroughly assess all reported issues or initiate a corrective and preventive action plan in a timely manner. The FDA highlighted that this failure to analyze and investigate complaint data may have contributed to delays in recognizing that the incompatibility risk extended to additional sizes of Cardinal Health Monoject syringes.
Syringe Quality Issues: FDA Warning Letter to Jiangsu Shenli Highlights Regulatory Violations
The warning letter issued to Jiangsu Shenli on July 18 described other quality system regulation violations. During a March visit to Jiangsu Shenli’s facility, FDA inspectors found no documentation related to the design and development of a range of syringes exported to the U.S., including enteral feeding syringes. These enteral feeding syringes were outside the scope of the original investigation, but the inspection findings led the FDA to include them in the import alert against Jiangsu Shenli. The FDA recommended that healthcare providers immediately transition away from using these devices.
These actions by the FDA underscore the agency’s commitment to ensuring that medical devices entering the U.S. market meet stringent safety and quality standards. By issuing warning letters and expanding import alerts, the FDA aims to mitigate potential risks associated with substandard medical devices. The investigation into the practices of Jiangsu Shenli and Jiangsu Caina highlights the importance of robust quality management systems and thorough compliance with regulatory requirements in the production of medical devices.
The FDA’s proactive measures are crucial in safeguarding public health, particularly in the context of widespread use of medical devices like syringes. Ensuring that manufacturers adhere to high standards of quality and safety is essential to prevent adverse events and maintain the integrity of the healthcare system. As the FDA continues to monitor and regulate medical device production globally, it remains vigilant in protecting the health and safety of patients in the United States.
In conclusion, the FDA’s recent actions against Jiangsu Shenli Medical Production and Jiangsu Caina Medical reflect the agency’s rigorous approach to ensuring the safety of medical devices. The warning letters and expanded import alerts serve as a reminder to all medical device manufacturers of the critical importance of compliance with quality system regulations. These steps are vital in maintaining the trust and safety of the healthcare system, ultimately benefiting patients and healthcare providers alike.
Resource: Food and Drug Administration, July 18, 2024
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