US FDA Issues Warning Letters to Two Chinese Firms for Violating Laboratory Practices, According to Reuters

The U.S. Food and Drug Administration (FDA) issued warning letters to two Chinese third-party testing firms, highlighting serious deficiencies in oversight and animal care practices. This raises significant concerns about the reliability and integrity of the data produced by these laboratories.

The warning letters were sent to Mid-Link Testing Company and the Sanitation & Environmental Technology Institute of Soochow University, located in Tianjin and Suzhou, respectively. These laboratories provide crucial testing and validation data services to medical device manufacturers, which they utilize for regulatory submissions.

Following inspections conducted earlier this year, the FDA reported widespread failures in data management, quality assurance, staff training, and oversight at these facilities, potentially resulting in the use of questionable data. The agency indicated it is currently assessing how these issues may have affected previous submissions and will take appropriate actions to mitigate any public health risks that may arise.

Skepticism regarding studies conducted in China is not new among U.S. lawmakers. In 2022, the FDA rejected treatment applications from Eli Lilly and Hutchmed, citing that the studies supporting these treatments were exclusively conducted in China.

Additionally, in 2023, the FDA advised against the use of certain syringes manufactured in China, prompted by reports of leaks, breakages, and other quality concerns related to the products. The FDA has maintained its efforts to evaluate quality issues surrounding syringes from China in the period since.