FDA issues warning letters to two Chinese firms over data integrity concerns

The U.S. Food and Drug Administration (FDA) has issued warning letters to two Chinese nonclinical testing laboratories, citing concerns about laboratory oversight and animal care violations. The labs, Mid-Link Testing Company in Tianjin and the Sanitation & Environmental Technology Institute of Soochow University in Suzhou, provide third-party testing and validation data services for device manufacturers’ premarket submissions to the FDA.

Following inspections earlier this year, the FDA identified failures in data management, quality assurance, and staff oversight at both labs. These findings include inaccuracies in recording and verifying research data, raising concerns about the reliability of safety data collected from the facilities. According to the FDA, this unreliable data could compromise premarket device submissions. Additionally, violations related to animal care were noted, with one firm failing to provide adequate care for test animals. Both firms were cited for failing to properly identify and record animals used in testing.

Owen Faris, Ph.D., acting director of the Office of Product Evaluation and Quality at the FDA’s Center for Devices and Radiological Health, emphasised the importance of maintaining safety and quality wthin the medical device industry. “The FDA will take action to protect patients, consumers, and the medical device supply chain from quality failures and violative practices,” Faris said. He added, “We strenuously remind industry of their responsibility and accountability for all data included in their submissions, which are required to comply with federal law.”

The FDA continues its review of data submitted by these labs and has indicated that it will not authorise submissions using unreliable data. The agency is also evaluating the potential impact on past submissions and will take further action if public health risks are identified. In addition, the FDA has requested that both firms submit corrective action plans within 15 working days.

Earlier this year, the FDA alerted the medical device industry to issues surrounding third-party lab data in device submissions. The agency stressed the importance of carefully reviewing any data not generated by the device sponsor, reiterating that outsourcing does not relieve sponsors of their responsibility for the accuracy of regulatory submissions. The FDA’s ongoing review includes submissions from these third-party testing labs, and it will continue to monitor and address any concerns regarding data quality and integrity.

Nonclinical laboratory studies, conducted under controlled conditions to assess the safety of test articles, are crucial to ensuring that medical devices meet regulatory standards. The FDA remains focused on ensuring the accuracy of such data, particularly from third-party labs, and will take action as necessary to uphold public health standards.