US FDA sends warning letters to two Chinese firms for violating lab practices

(Reuters) -The U.S. Food and Drug Administration issued warning letters to two Chinese third-party testing firms on Wednesday, citing oversight failures and animal care violations, raising concerns about the quality and integrity of data generated by the labs.

The letters were issued to Mid-Link Testing Company and Sanitation & Environmental Technology Institute of Soochow University, which are located in the Chinese cities of Tianjin and Suzhou, respectively.

The laboratories provide testing and validation data services to medical device manufacturers for use in their marketing application submissions to the regulator.

The FDA said it inspected the firms earlier this year and found pervasive failures with data management, quality assurance, staff training and oversight, which could lead to use of unreliable data.

The regulator added it was evaluating any impact these findings may have had on past application submissions and will take necessary action to address any public health risks.

U.S. lawmakers have often doubted studies conducted in China. The FDA had declined approval in 2022 for treatments from Eli Lilly and Hutchmed that were tested only in China.

The FDA had in 2023 recommended against the use of some syringes originating from China as it investigated reports of leaks, breakages and other quality problems with such products.

Since then, the regulator has continued efforts to evaluate problems with syringes made in China.

(Reporting by Sneha S K and Puyaan Singh in Bengaluru; Editing by Krishna Chandra Eluri)