Medical Device Network

FDA warns two Chinese companies for violating lab practices

The US regulatory agency sent warning letters to two Chinese nonclinical testing laboratories, citing laboratory oversights and animal care violations.

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.

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.

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.

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.