Theranos' beleaguered founder, Elizabeth Holmes, may be banned from heading or working in her own labs, and her company's license to operate its laboratory in Newark, California may be revoked.
Despite Theranos' assurances to the contrary, federal regulators say the company has not fixed deficiencies at the lab, some of which the government classified as life-threatening, identified in a November inspection.
The news broke in the Wall Street Journal, which has broken just about all of the news on Theranos' decline since last fall.
'(W)e have determined that the laboratory's submission does not constitute a credible allegation of compliance and acceptable evidence of correction ..." the agency wrote to Theranos in a letter dated March 18, portions of which were posted online by the Journal.
As a result, CMS is threatening to ban founder Elizabeth Holmes and president Sunny Balwani from lab operations for at least two years, the Journal says. CMS is also threatening to revoke the Newark lab's federal license, which means the lab will no longer be allowed to perform any testing.