FDA May Disqualify 2 Chinese Labs Over Unreliable Data, Lab Violations

The FDA said there has been an ‘alarming’ rise in unreliable data submitted by manufacturers for premarket approval, often coming from labs in China and India.

The U.S. Food and Drug Administration in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The U.S. Food and Drug Administration (FDA) issued warnings on Sept. 10 to two Chinese test labs over animal testing violations and oversight failures that have led to unreliable data, starting a countdown to potential disqualification proceedings.

One of the labs is Mid-Link Testing Company Ltd. in Tianjin, China, and the other is Sanitation & Environmental Technology Institute of Soochow University Ltd. in Suzhou, China.