Skip to main content
Premium Trial:

Request an Annual Quote

Second Failure

A second Theranos lab failed an inspection by regulators, the Wall Street Journal reports.

A September inspection by the Centers for Medicare and Medicaid Services uncovered deficiencies at Theranos' Scottsdale, Ariz., lab, its only working lab at the time. An earlier inspection of the firm's California lab also revealed deficiencies, including ones regulators said posed immediate danger to patients. That California inspection led to sanctions, including banning CEO Elizabeth Holmes from owning or running a clinical lab, a decision the firm is appealing. This new inspection places the company at risk for further sanctions, the Journal adds.

A source tells the Journal that Theranos submitted a plan to CMS to address the deficiencies at the Arizona facility, but that the agency rejected it and instead proposed sanctions.

Theranos closed its California lab over the summer, but continued to test samples at its Scottsdale facility. It then announced in late October that it would be closing all its labs to refocus its energies on developing its new miniLab platform.

The company tells the Journal that its plan to close its lab was in the works before the CMS inspection.

CMS has not yet made its inspection report or letter to Theranos public, the Journal notes.