SAN FRANCISCO — Pressure on Silicon Valley biotech startup Theranos increased Tuesday with the Food and Drug Administration’s release of complaints against the bloodwork company based on facility inspections earlier this summer.
The documents specifically cited the company’s unique nanotainer, which is used to collect a few drops of blood through its FDA-approved finger-stick method, as being an “uncleared medical device” that should not be shipped out of Theranos’ home state of California to its lab locations in Arizona and Pennsylvania. Also, Theranos did not adequately look into whether the small containers might obscure the clotting of blood, the FDA said.
These complaints were among 14 “observations” the FDA listed in two Form 483 reports compiled after visits to Theranos facilities between late August and mid-September. The agency publicly posted the findings after Freedom of Information Act requests were filed by The Arizona Republic and other media outlets.
The issues cited generally focus on matters involving the handling of customer complaints and the vetting of suppliers, and taken in total would appear to describe a company that doesn’t have the level of back-office rigor one might expect of a $9 billion firm. In some instances, the FDA inspectors noted that while Theranos officials attempted to fix some of the problems raised during the inspections, they way they did so didn’t meet the agency’s standards.
In one section, the inspectors wrote: “Specifically, you undertook several corrections of your Quality Management System procedures and records without documenting the investigations or causes of the non-conformities, the actions needed to correct or prevent recurrence of similar quality problems, the verification or validation of corrective actions, and the dissemination of information about the quality problems to responsible parties.”
Theranos CEO Elizabeth Holmes, 31, who owns half the company, has been adamant about her desire to work with the FDA as it goes about vetting the new company, citing the FDA’s approval earlier this year of its innovative and low-impact blood draw as well as its approval for Theranos labs to test for the herpes simplex 1 virus.
A blog post on the company’s website earlier this month emphatically noted that its nanotainer “has already been cleared by FDA for use with our HSV-1 test. FDA had to review and clear all our proprietary systems, including the nanotainer tubes, in order to clear even this one test. Why? Because we’re innovative. Because we are doing things differently. Now we’re working with them on clearance of just the nanotainer tubes across all tests. But it’s the same tube. We’ve already met their rigorous standards in our first submission on our systems, and we’ll continue to do so.”
While the FDA Form 483 is not as serious as a warning letter, it does shed light on hurdles the secretive company is facing as it attempts to reinvent the blood-testing industry that has long been dominated by companies such as LabCorp and Quest Diagnostics. Holmes, who dislikes needles, has repeatedly stated that she dropped out of Stanford University to start Theranos out of a mission to make blood testing both easier and cheaper so as to encourage consumers to more closely monitor their own health without the need for a doctor’s prescription.
Theranos has enjoyed a long honeymoon period as it has built up its coffers (some $400 million in funding) and staff (which includes a range of well-known politicians and former military officials). But it has come under intense scrutiny of late after a Wall Street Journal report quoted unnamed former employees who questioned the efficacy and reliability of the company’s proprietary equipment. At every turn, Holmes has strongly rebutted the report as being inaccurate and has insisted the company is eagerly working with federal officials, doing so both in blog posts and in person during an appearance at the Journal‘s tech conference last week.
“If someone’s writing anything, they are writing FDA submissions, and that’s our full-time job right now,” Holmes said at the Wall Street Journal Digital Live conference in Laguna Beach, Calif.
On Monday, Holmes appeared at a conference sponsored by the Cleveland Clinic, where she said Theranos would begin publishing the results of tests that spoke to the accuracy and reliability of its testing methods. “Data is a powerful thing because it speaks for itself,” she said.
Follow USA TODAY tech reporter Marco della Cava on Twitter: @marcodellacava
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