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.

The labs conduct third-party testing and validate data for device manufacturers to submit to the FDA for market approval. Tests conducted included those related to toxicity, cell death, red blood cell breakdown, as well as animal testing.

After inspections earlier this year, the FDA found the data supplied by these firms unusable for the manufacturers’ premarket submissions. The FDA says reviews into these firms are ongoing.

“The medical device industry must be built and sustained on safety, effectiveness and quality,” said Owen Faris, acting director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health.

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