FDA Says Theranos Has Not Followed Federal Regulations for Medical Device

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Theranos and its finger-prick blood-testing technology has come under siege from a Wall Street Journal investigation. (Theranos)

Federal regulators released inspection reports today saying Theranos has improperly classified its blood-testing device as exempt from listing and has been "shipping this uncleared medical device in interstate commerce, between California, Arizona, and Pennsylvania."

The Food and Drug Administration documents say Theranos' blood testing device is a Class II device that must be listed for FDA review and clearance, and that the company has not listed it.

The FDA documents also say Theranos had inadequate procedures for reviewing complaints -- including complaints that a device may have been faulty -- and they note several other deficiencies in Theranos' procedures.

The documents summarize observations made during an inspection, but do not represent an official decision about whether Theranos is out of compliance with federal regulations.

This comes nearly two weeks after the Silicon Valley biomedical start-up stopped selling all but one of its finger-stick tests under pressure from the FDA. The Wall Street Journal reports:

The FDA inspection confirms an article published by The Wall Street Journal on Oct. 16 that said Theranos had stopped using the vials for all but one test under pressure from the agency, citing a person familiar with the inspection. 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.

Theranos didn’t immediately provide a comment Tuesday.

The FDA inspection, which spanned Aug. 25 to Sept. 16, also found a number of deficiencies in Theranos’s quality-assurance processes, the reports show. Among them, Theranos didn’t investigate whether the suppliers of materials it used had met the company’s quality requirements, according to one of the reports. In addition, Theranos was “unable to produce documented supplier qualifications,” the report said.

    FDA Inspection Reports: