FDA inspection found problems at now beleagured Theranos

Theranos Inc., a high-profile Silicon Valley medical testing company valued at $9 billion, turned heads with assertions that it can perform a multitude of medical tests with just drops of blood pricked from fingers. But it received unwelcome attention earlier this month when a Wall Street Journal article called into question the accuracy of the company’s testing technology.

Today, the Food and Drug Administration released two inspection documents that validate some of the issues raised in the article. In the documents, the agency called the company’s tiny blood vials “uncleared medical devices,” noted quality assurance issues, and found that the company did not properly investigate customer complaints.

In an e-mailed statement to the WSJ, Theranos general counsel Heather King said the company has “addressed and corrected” all the problems flagged by FDA inspectors.

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