In September, the United States Food and Drug Administration (FDA) sent Silicon Valley startup Theranos two inspection notices wherein government inspectors found upsetting conditions that they believed were illegal.
The FDA documents did little to shed light on the dark clouds surrounding the highly celebrated and secretive blood tech startup that is currently fighting a public battle for its reputation.
The two FDA documents are public documents. Copies were uploaded online but they were just as hard to decipher as most sections were blackened out. Still, FDA's three-week inspections of the Theranos' two facilities in August and September drew blood. Federal officials expressed that the hot startup, which is dead set on revolutionizing the blood test industry, had a list of questionable actions.
These include the misclassification of the Nanotainer device as a 'Class I exempt' or a 'low-risk medical device'. Theranos should have classified the blood collection device as a 'Class II' which requires more regulation controls to ensure the device's safety and effectivity. In comparison, dental flosses are classified as Class I devices while condoms are classified as Class II.
In the FDA report, the federal agency said "You are currently shipping this uncleared medical device in interstate commerce, between California, Arizona and Pennsylvania." FDA observations [pdf] also highlighted the device design's lack of validation to "ensure the device conforms to defined user needs and intended uses." Moreover, the FDA documented Theranos' failure to keep sufficient records and documentations, conduct quality audits and handle complaints from consumers effectively.
"We believe that we addressed and corrected all the observations at the time of, or within a week of, the inspection," said Theranos in an emailed statement.
Adding to the bloody war is Walgreen's announcement that they halted their plans to work with Theranos until things become clearer. Walgreens is one of the start-up's biggest investors along with Cleveland Clinic whose spokeswoman, Eileen Sheil, cleared through email that their partnership with Theranos is in its primary stages and the clinic has not used any of Theranos' proprietary technology.
In a statement, Theranos expressed its interest in possibly publishing data that will explain the tests performed using its proprietary technology in order to demonstrate to people how its devices work.
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