(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."
The name of the device was redacted. In addition, "the design was not validated under actual or simulated use conditions."
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