WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently issued warning letters to two Chinese nonclinical testing laboratories. The letters, sent to Mid-Link Testing Company Ltd. in Tianjin and the Sanitation & Environmental Technology Institute of Soochow University Ltd. in Suzhou, highlight significant oversight failures and animal care violations that could undermine the integrity of data used in premarket submissions.
These laboratories play a critical role by providing third-party testing services to medical device manufacturers. The FDA’s inspection earlier this year revealed troubling deficiencies in data management, quality assurance, and staff training. Particularly concerning was the failure to accurately record and verify essential research data, raising doubts about the credibility and reliability of safety evaluations conducted at these facilities. Such lapses could result in flawed data being included in device submissions, potentially impacting the FDA’s marketing authorization decisions.
Animal care violations were also cited, with one laboratory failing to provide adequate care and both not properly identifying and recording test animals. These issues highlight broader concerns about operational standards at these facilities.
Owen Faris, Ph.D., acting director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health, emphasized the gravity of these findings: “The medical device industry must be built and sustained on safety, effectiveness, and quality. The FDA will take action to protect patients, consumers and the medical device supply chain from quality failures and violative practices. 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 has reiterated the importance of high standards in nonclinical laboratory studies, which are vital in assessing the safety of test articles under laboratory conditions. While device sponsors may utilize third-party labs, they remain responsible for ensuring the accuracy of all data submitted for regulatory approval.
The FDA has requested that the laboratories respond within 15 working days, detailing corrective measures to address the identified issues. The agency remains vigilant, continuing to evaluate data from third-party testing labs and taking necessary actions to safeguard public health. This initiative highlights the FDA’s proactive approach to maintaining the integrity of the medical device industry and protecting consumer safety.
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