(Bloomberg) — Blood-testing startup Theranos Inc., under fire after reports that the company overstated the ability of its tests to accurately perform several dozen types of measurements, has flaws in the process it uses to validate its products, Food and Drug Administration inspectors found.
Heavily redacted inspection reports, posted Tuesday by the U.S. FDA, said that Theranos's "design validation did not ensure the device conforms to defined user needs and intended uses."
The name of the device was redacted. In addition, "the design was not validated under actual or simulated use conditions."
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The inspections were conducted Aug. 25 through Sept. 16 at Theranos's Palo Alto and Newark, California, offices.
Theranos claims its technology can run finger-stick samples for tests that have typically required an entire vial of blood. "We are confident in the reliability of our tests, because we comprehensively validate the accuracy of every test we run," Theranos said in a statement Oct. 22.
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.
Theranos wasn't able to immediately comment on the FDA inspection reports. The FDA didn't immediately respond to questions asking for more information on the reports.
In a statement last week, Theranos said it was working with the FDA to validate its tests. "We initiated filings with FDA two years ago — by choice, not necessity — because we are seeking to create a new model for laboratory testing standards," Theranos said. "In our discussions with FDA, we determined that it was appropriate to temporarily pause use of the Nanotainer tubes for all tests."
The FDA reports also said Theranos's blood-collection device, which Theranos describes as a capillary tube nanotainer, is a class II medical device, which is considered higher-risk than the class I Theranos had categorized it as.
"You are currently shipping this uncleared medical device in interstate commerce, between California, Arizona, and Pennsylvania," the FDA document said.
After limiting the technology's use, the company has said it will resume using the nanotainers and associated testing technology once the FDA reviews and clears more types of tests offered by Theranos and using its technology.
In the meantime, Theranos is using traditional vein draws for everything but the herpes test, which was cleared by the FDA in July.
The accuracy of Theranos's technology was questioned in a Wall Street Journal article this month. Theranos has disputed the article's claims, and the Journal has said it stands behind the story.
FDA also listed inspection observations that many startup testing companies unfamiliar with U.S. regulations get slapped on the hand for, including inadequate procedures for evaluating complaints and documenting corrective actions.
The latest company to receive such a notice was Merge Healthcare Inc., which was purchased by IBM for $1 billion earlier this month. Merge received a warning letter Sept. 30 for failing to show it had adequately reviewed or evaluated complaints.
–With assistance from Caroline Chen in San Francisco.
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