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Theranos Inspection Report Details Quality-Control Failures

  • Regulators found incomplete documentation, unqualified staff
  • Blood-testing startup says new procedures are now in place
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An inspection report of Theranos Inc. released late Thursday by U.S. regulators paints a picture of an understaffed and inexperienced startup struggling to meet basic requirements, let alone deliver on its promise to revolutionize the blood-testing industry.

The 121-page redacted report details shortcomings found by inspectors for the Centers for Medicare and Medicaid Services at the company’s Newark, California, laboratory last fall. CMS said in late January that faults at the lab were so severe that they jeopardized patients’ health. The document makes public the details of these issues for the first time.