- Between August 25 and September 16, the FDA visited two California-based Theranos offices, including one in Palo Alto and another in Newark, CA.
- The reports, which were posted yesterday, were heavily redacted; however, it was evident that the FDA is questioning Theranos' quality assurance program and criticizing the startup's habit of shipping its small blood vial 'nanotainers,' which the agency called an uncleared medical device, across state lines.
- Theranos claims that is has addressed, and in some cases corrected, the situations which the FDA tagged as sources of concern.
It's another tough day for Theranos, made worse by the firestorm of attention the company has received over the last couple of weeks. First, the Wall Street Journal published a piece alleging that the company wasn't really using its proprietary "Edison" blood testing technology. Then, the FDA told Theranos to stop using its finger-prick tests for everything other than herpes testing, for which the company has regulatory clearance. And now, regulators have released inspection reports showing that Theranos must address several deficiencies in its business tactics.
Nonetheless, there is more to the story. In 2013, Theranos reached out to the FDA with the goal of becoming an FDA-regulated device manufacturer, instead of simply operating without any regulatory approvals or oversight. Theranos initiated the transition process, and it got tricky along the way.
The FDA went on to classify the nanotainer device as a Class II device, which is considered higher risk than Class I devices. In its inspection reports, the FDA called out Theranos on shipping an uncleared medical device between states.
Theranos is not the only start-up to have challenges during FDA inspections, and the company says that it has pre-submitted 120 of its tests to the FDA to obtain additional guidance with the process.