Biotech
Wednesday, March 20th, 2024 4:49 pm EDT
Key Points
- FDA warning: The U.S. FDA has issued a safety communication highlighting widespread quality control issues with Chinese-made plastic syringes distributed in the U.S., surpassing previous knowledge of the problem. Three Chinese syringe manufacturers were found to be in violation of FDA regulations, prompting the agency to send warning letters.
- Investigation findings: CNBC’s investigation, prompted by the FDA’s initial review in November, revealed numerous reports of quality and performance issues with plastic syringes, including leaks, breakage, and foreign matter. The agency received over 4,000 reports related to plastic syringe issues in 2023 alone, indicating a broader concern beyond Chinese manufacturers.
- Safety measures and recalls: FDA advises immediate transition away from certain Chinese-made syringes and urges monitoring for defects in others. Major pharmaceutical companies like McKesson, linked to some manufacturers, are advised to switch to alternative products. Cardinal Health and Fresenius Medical Care have faced class one recalls for syringe issues, with concerns ranging from dosage inaccuracies to syringe leakage. Despite these challenges, FDA believes alternative supply and manufacturing capabilities are sufficient to prevent shortages and commits to ongoing evaluation of syringe issues, particularly those from China.
The U.S. Food and Drug Administration (FDA) has issued a safety communication warning about Chinese-made plastic syringes distributed in the U.S., revealing more widespread quality control issues than previously acknowledged. Three Chinese syringe manufacturers were found to be in violation of FDA regulations, prompting the agency to send warning letters to them and two U.S. firms involved in marketing and distributing these syringes. Reports of issues with plastic syringes, including leaks and breakage, have prompted this action, with over 4,000 reports received by the FDA in 2023 alone. Some reports noted foreign matter in syringes, multiple needle breakages, and inaccuracies in vaccine measurements. While the FDA urges transitioning away from certain Chinese-made syringes, it acknowledges the need for continued monitoring for defects in others. Major pharmaceutical companies like McKesson, linked to some of these manufacturers, are advised to transition to alternative products. Cardinal Health and Fresenius Medical Care have also faced issues with their syringes, leading to class one recalls due to dosage inaccuracies and safety concerns. Despite these challenges, the FDA believes there is sufficient supply and manufacturing capability of plastic syringes outside of China to prevent shortages and commits to ongoing evaluation of the issue.
For the full original article on CNBC, please click here: https://www.cnbc.com/2024/03/20/fda-safety-issues-with-china-made-syringes-more-widespread-than-initially-known.html
