The FDA reports also posit that the consumer healthcare company is inadequately addressing quality standards and customer complaints.
In another blow to embattled blood testing startup Theranos, the FDA posted inspection reports on Tuesday that reveal potentially disastrous pitfalls for the company. The FDA calls the miniature vial used by Theranos to collect blood samples an "uncleared medical device" and notes that the company has been shipping it across state borders. These findings bolster the Wall Street Journal's extensive reporting on Theranos over the past two weeks, which stated that the company was now using the vials for its herpes test alone—the only Theranos blood test the FDA has approved thus far.
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