Blood-testing start up Theranos, under fire after U.S. Food and Drug Administration inspectors found. Heavily redacted inspection reports were conducted Aug. 25 through Sept. 16, posted Oct.27 by the FDA, said Theranos's "design validation did not ensure the device conforms to defined user needs and intended uses."

In the first document, the FDA says the “nanotainers” should be listed as a Class II medical device, though Theranos currently lists it as a Class I exempt device. The distinction means the device needs FDA approval if it is to be shipped across state lines. “You are currently shipping this uncleared medical device in interstate commerce,” the document says, “between California, Arizona and Pennsylvania.” The document also says complaints “were not reviewed, evaluated and investigated where necessary.”

In a second document, the FDA criticizes Theranos for not clearly describing its processes in writing. “Design validation did not ensure the device conforms to define user needs and intended uses,” the form says.

"We believe that we addressed and corrected all the observations at the time of, or within a week of, the inspection," Theranos said in an emailed statement. "We are charting new pathways, and are working to create a model for the transition," Theranos said.

Theranos said it decided to stop using its nanotainers in all except the herpes test, which the FDA cleared in July. In the meantime, Theranos is using traditional vein draws for everything else.