Theranos is best known for a device that can test blood samples without using traditional needles. After the Journal article, Theranos founder and Chief Executive Elizabeth Holmes confirmed the company had sharply curtailed its use of the vials, which it calls nanotainers, but presented it as a voluntary move.
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Neglected customer complaints cited in the document include reports that the nanotainers were “too opaque to be able to see clotting clearly”.
The FDA reports said Theranos’s blood-collection device, which the company describes as a capillary tube nanotainer, is a Class II medical device, which is considered higher-risk than the Class I that Theranos had categorized it as. At the conclusion of the inspection, FDA issued two Form 483s outlining observations made during the inspection.
“Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated when necessary”, the FDA said in its notice.
Regulators said that quality audits had not been performed at the facility and that Theranos did not lay out an internal quality audit schedule.
The inspectors also deemed inadequate the company’s compliance with listing, documentation, quality assurance, audit requirements and more. Theranos has applied for FDA approval for other tests.
Earlier this week, Theranos’ partner Walgreens Boots Alliance ($WBA) said that it would not open any new Theranos blood-testing centers at its drugstores until the startup answers a few questions regarding its technology. So far in contrast to standard practice, the company has not published any data on its tests in peer-reviewed journals. While the company lists about 200 tests on its online menu, the company said this month that it is using its new technology on only one, a herpes test.
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In addition, a couple of key FDA observations show the company did not seem to have enough proof of its claims about its technology: “Design validation did not ensure the device conforms to defined user needs and intended uses”, and “the design was not validated under actual or simulated use conditions”. “But that’s OK, we can publish data, and we’re doing that”.
