US FDA sends warning letters to two Chinese firms for violating lab practices (updated)
11/09/2024 19:18
(Adds background in paras 6-8)
Sept 11 (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 LLY.N and Hutchmed 0013.HK 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)
((Sneha.SK@thomsonreuters.com;))