U.S. health inspectors have found deficiencies at Theranos' lab in Newark, Calif., and the blood-testing company could face suspension from the Medicare program if it does not fix the problems, according to The Wall Street Journal.
People familiar with the matter told WSJ the deficiencies were found during a CMS inspection. The specific problems regulators identified have not been released, but people familiar with the matter told WSJ the inspection results are expected to be publicly released soon.
Brooke Buchanan, a Theranos spokeswoman, told WSJ the company does not have CMS' audit report from last year's inspection of its California lab.
It will be a significant blow to Theranos if the CMS inspection report includes adverse findings, as the Palo Alto, Calif.-based startup has already suffered regulatory setbacks. For instance, in October, the Food and Drug Administration found that the company's proprietary vials called "nanotainers" were an uncleared medical device, according to WSJ. Theranos is now only using its exclusive Edison technology to collect and test tiny nanotainers of blood for just one test.
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