A lab operated by controversial blood testing startup Theranos poses "immediate jeopardy to patient health and safety," the Centers for Medicare & Medicaid Services said in a letter released Wednesday.
CMS detailed five different conditions the California lab did not meet, including those relating to its director, technical supervisor and personnel.
The letter, dated Monday, gives the company 10 days to correct the noted deficiencies. It also notes that the company can face daily fines for noncompliance and/or the loss of its approval to receive Medicare payments.
Theranos has been under fire for months after a series of reports in the Wall Street Journal raised questions about the quality of its testing technology.
The company, in a statement, said it was responding to the letter.
"This survey of our Newark, CA lab began months ago and does not reflect the current state of the lab. As the survey took place we were simultaneously conducting a comprehensive review of our laboratory's systems, processes and procedures to ensure that we have best-in-class quality systems," the company said.
"We value engagement with our regulators, and are committed to ensuring that all our labs operate at the highest standards. We are still reviewing the report, but we addressed many of the observations during the survey and are actively continuing to take corrective action. A full plan of correction will be submitted to CMS within days."
Theranos also said none of the CMS findings applied to another lab the company runs in Arizona, where it said it processes the majority of its tests.