FDA releases reports of Theranos inspection: 5 things to know

The Food and Drug Administration released two documents Tuesday following inspections of Palo Alto, Calif.-based Theranos.

The company has been under fire since a pair of Wall Street Journal reports came out earlier this month alleging the company overstated the capability of its product and that the FDA pressured the company to stop using its finger-prick technology for all but one test. Theranos founder and CEO Elizabeth Holmes called the WSJ coverage false and misleading, though did confirm it was voluntarily using its proprietary technology for just one test.

Here are five things to know about the latest in the Theranos saga — the results of the FDA inspections.

1. The FDA reports say the company's "nanotainer," which is a tiny vial of blood collected from a finger prick, was "uncleared" and was being shipped in interstate commerce, according to The New York Times.

2. The documents indicate the company dialed back the use of the finger-prick test by FDA request, according to the report. Theranos previously stated it did this voluntarily to switch to FDA framework. Ms. Holmes said in an interview with WSJ this decision had nothing to do with the accuracy of the technology or capability of the devices.

3. The FDA inspection examined the company's operations from late August to mid-September after the organization had approved one test for herpes. The FDA did not inspect Theranos' labs, according to The New York Times, as these are not FDA-regulated.

4. The documents observed 14 issues at the company, primarily about quality assurance procedures and documentation, according to the report. Finding issues during an FDA inspection is "not uncommon," according to The New York Times, and less serious than receiving a warning letter.

5. Theranos said in a statement it addressed and corrected all the issues within a week of the inspection. According to The New York Times, inspectors have not yet confirmed all the corrections were completed.

Read the FDA reports here.

 

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