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US FDA warns two Chinese companies for lab violations

The U.S. Food and Drug Administration sent warning letters on Wednesday to two Chinese third party testing companies, citing oversight failings and animal abuse violations. This raised concerns about the integrity and quality of the data generated by these labs.

The letters were sent to the Sanitation & Environmental Technology Institute at Soochow University and Mid-Link Testing Company, both located in Tianjin, China.

Medical device manufacturers can use the data from these laboratories to submit their marketing applications to regulators.

The FDA stated that it had inspected these firms earlier this summer and found widespread failures in data management, quality control, staff training, and oversight. This could lead to the use of unreliable information.

The regulator said it would evaluate the impact of these findings on previous application submissions, and take any necessary actions to address any potential public health risks.

U.S. legislators have frequently questioned studies conducted in China. In 2022, the FDA declined to approve treatments developed by Eli Lilly and Hutchmed which were only tested in China.

In 2023, the FDA recommended against using some syringes that originated from China after it had investigated reports of leaks and quality issues with these products.

Since then, regulators have continued to assess problems with syringes manufactured in China.

(source: Reuters)