Here's What Troubled The FDA When It Inspected Theranos This Summer

The agency raised concerns about whether the blood testing startup had properly vetted its technology.

Theranos founder and CEO Elizabeth Holmes.

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Theranos, the much-hyped Silicon Valley startup valued at an eye-popping $9 billion, has been facing questions over whether its proprietary technology can actually do what it claims: diagnose diseases and health conditions from a few drops of blood.

The Wall Street Journal first raised those questions in an Oct. 16 story, followed by a report that Theranos recently stopped collecting tiny vials of blood for all but one of its tests after a recent FDA inspection. Theranos has defended itself, saying that the stories "say or imply many things that are simply wrong"; the WSJ has stood by its reporting.

The saga took another twist Tuesday when the FDA posted documents from that inspection during late August and September in response to public records requests. As heavily redacted and jargon-filled as they are, they don't look great for Theranos: The FDA questioned whether its technology was validated, called its blood vial "uncleared," and said the company wasn't set up to handle customer complaints or vet its internal processes.

The agency ​argued that​ Theranos failed to show adequate proof, in real or simulated conditions, that ​its technology lived up to what it claimed to do.

"Given the number of observations that relate to the same sorts of topics, I think it's fair to say generally that the FDA is concerned about the validation under the appropriate conditions of the design" of the technology, Patti Zettler, an associate professor of law and FDA expert at Georgia State University, told BuzzFeed News.

The agency also said that ​Theranos' "nanotainer" — its tiny vial for drops of blood — isn't cleared​ by the FDA or properly classified according to FDA definitions, yet Theranos was sending them throughout California, Arizona, and Pennsylvania. "If that observation holds, that's a pretty clear violation of the law," Zettler said.

The documents:

FDA

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