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FDA Issues Warning Letters to Two Chinese Firms for Data Quality and Integrity Concerns, Violative Lab Practices

Today, the U.S. Food and Drug Administration (FDA) issued warning letters to two Chinese testing laboratories, relating to quality assurance and data integrity concerns, laboratory oversight failures and animal care violations. Warning letters were issued to Mid-Link Testing Company Ltd. in Tianjin, China, and Sanitation & Environmental Technology Institute of Soochow University Ltd. in Suzhou, China. The firms provide third-party testing and validation to device manufacturers for use in their premarket device submissions to the FDA.

The FDA continues to conduct a rigorous review of data generated from these test facilities submitted in premarket submissions and does not intend to authorize submissions where data are found to be unreliable.

Questions?

If you have questions, contact the Division of Industry and Consumer Education.