The FDA has requested the two entities notify the FDA of their corrective actions to be taken within 15 working days of receiving the letters. Image credit: rafapress / Shutterstock.

The US Food and Drug Administration (FDA) has sent warning letters to two Chinese nonclinical testing laboratories regarding laboratory oversight failures and animal care violations.

The regulatory agency raised concerns about the quality and integrity of the lab data. The warnings were issued to Mid-Link Testing Company based in Tianjin, and Sanitation & Environmental Technology Institute of Soochow University in Suzhou.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

The two companies provide third-party testing and validation data services to device manufacturers for use in their regulatory premarket device submissions.

The FDA stated that it plans to “conduct a rigorous review” of data generated from these test facilities. The agency added that it “does not intend to authorise submissions” for devices where the data generated from these labs were necessary to grant the marketing authorisation. Furthermore, the agency plans to retroactively look at the past submissions where data from these labs were used and “will take action to address any public health risks as necessary”.

The FDA first raised concerns about “fraudulent or unreliable data” in February 2024. The agency warned device manufacturers and sponsors to ensure they double-check the results provided by some third-party test labs after discovering that some of these labs are generating data that is either fabricated or in some cases pulled from other device submissions to the FDA.

See Also:

While the agency did not name specific labs at the time, it noted that many of the submissions contained fraudulent data provided by third-party test labs based out of China or India.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The recent warning letters also noted animal testing violations. Per the FDA, both firms failed to provide adequate identification and recording of the animals used in the labs’ testing, with one firm failing to provide adequate care for the animals. The agency reiterated its warning that “while a device sponsor may use a third-party lab for nonclinical studies, doing so does not relieve the device sponsor of the responsibility to ensure the accuracy of data included in their regulatory submission”.

The US regulatory agency has requested the two Chinese companies notify the FDA of their corrective actions to be taken within 15 working days of receiving the letters.