Theranos feels FDA's wrath over proprietary testing device

Theranos' Palo Alto, CA, headquarters--Courtesy of Theranos

Last week, Theranos came under fire after a new report showed that the company stopped collecting tiny vials of blood for all but one of its more than 200 tests after the FDA paid it a surprise visit over the summer. Now the company is dealing with the fallout as the agency posted two Form 483s from its inspection, citing Theranos for violations related to its testing devices.

The forms, while heavily redacted, offer some insight into what regulators found when they visited Theranos' facilities in August and September. In a notice to Theranos CEO Elizabeth Holmes, the FDA said that the company's design for its capillary tube nanotainer (CTN) blood collection devices was "not validated under actual or simulated use conditions" and that Theranos did not adequately document risk or hazard analyses for its product.

Another Form 483, addressed to Theranos COO Ramesh "Sunny" Balwani, chastises the company for operating its product, which is manufactured and used by Theranos to collect blood samples, as an "uncleared medical device." Regulators told Theranos that it must have the tools officially approved before use.

Plus, Theranos does not have set procedures for dealing with customer complaints over its products, the agency said in its notice to Balwani. The Form 483 redacts a process that the Palo Alto, CA-based company "verbally described" during the FDA's inspection. But there's a discrepancy between Theranos' written procedures and those it verbally detailed during the inspection, the agency pointed out, suggesting a few kinks in the company's system.

"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.

The company also came under scrutiny for quality issues that turned up in a Sept. 16 inspection at its Newark, CA, manufacturing plant. 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 news comes as Theranos faces growing backlash over its testing devices after The Wall Street Journal published articles a couple weeks ago calling the company's proprietary technology into question. One of the stories showed that Theranos' lab device only handled a small fraction of its tests by the end of 2014. Another article said that the company limited its blood testing devices to one product as a result of the FDA's inspections in August and September.

Theranos CEO Elizabeth Holmes

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 some questions regarding its technology. The drug store chain currently offers Theranos testing at 41 stores in Arizona and California, but has "no concrete plans" to expand the relationship, a Walgreens official told the WSJ. "We're trying to figure out where we are and what we do going forward," the official said. "We need to understand the truth."

Meanwhile, Theranos is responding to calls for transparency. The company said this week that it would publish data validating the accuracy and reliability of its tests, The New York Times reports, trying to clear up uncertainty surrounding its products as it deals with a barrage of criticism. Theranos has not published data on its test in peer-reviewed journals, the NYT points out, and has largely focused gaining FDA approval for its tests as validation. In July, the company notched a win with FDA clearance for its finger-stick herpes test, a "milestone" for Theranos, Holmes said at the time.

"I just always believed that as the FDA decision summaries came out one by one with our data, that actually that would be so much more transparent a model," Holmes said this week at a conference in Cleveland, as quoted by the NYT. "But that's OK, we can publish data, and we're doing that."

- here's the Form 483 (PDF)
- and here's the other FDA inspection document (PDF)
- read the NYT story (sub. req.)

Special Reports: Top women in medical devices 2014 - Elizabeth Holmes, Theranos | Top 10 Medical Device Venture Capital Deals of 2010 - Theranos

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