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Theranos device validation is flawed, FDA finds

Blood-testing startup Theranos Inc.has flaws in the process it uses to validate its products, the FDA says.

By Anna Edney | Updated on October 27, 2015
Theranos CEO Elizabeth Holmes (photo: AP)

(Bloomberg) — Blood-testing startup Theranos Inc., under fire after reports that the company overstated the ability of its tests to accurately perform several dozen types of measurements, has flaws in the process it uses to validate its products, Food and Drug Administration inspectors found.

Heavily redacted inspection reports, posted Tuesday by the U.S. FDA, said that Theranos’s “design validation did not ensure the device conforms to defined user needs and intended uses.”

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