Data quality and integrity concerns, violative lab practices : US FDA issued warning letters to two Chinese firms

The US Food and Drug Administration (FDA) issued warning letters to two Chinese nonclinical testing labs—Mid-Link Testing Company Ltd. in Tianjin and Sanitation & Environmental Technology Institute of Soochow University Ltd. in Suzhou—citing laboratory oversight issues and animal care violations. These labs provide data services for premarket submissions to the FDA, and concerns were raised about the reliability of the data they generated. The FDA has stated that it will not authorize submissions relying on this data unless the issues are resolved. Inspections revealed failures in data management, quality control, and staff oversight, including the mishandling of test animals. The FDA is reviewing the impact on previous submissions and urging device manufacturers to carefully scrutinize third-party testing data. The agency has requested that both labs respond with corrective actions within 15 working days.