FDA throws the book at Theranos
The FDA just released documents related to its visit to Theranos' labs - and they don't look good.
Theranos, a $10 billion blood-testing company that says its blood tests can be done with a single drop of blood, has come under fire recently after a lengthy Wall Street Journal expose questioned just how revolutionary the startup was.
The reports are Form 483s, which are issued at the end of inspections when investigators see anything that may violate the Food Drug and Cosmetics Act. They're from an FDA visit which happened between August 25 and September 16, 2015 and are heavily redacted. Nevertheless, they are worrisome.
Take a look:
Notably, the forms relay observations about Theranos' proprietary "nanotainer" technology, small containers that collect tiny samples of blood.
The FDA claims that the containers Theranos has been using to collect blood, known as "nanotainers," never got regulatory approval: "You are currently shipping this uncleared medical device in interstate commerce, between California, Arizona, and Pennsylvania."
Here are some of the other main observations sent to Theranos CEO Elizabeth Holmes and President/COO Ramesh (Sunny) Balwani.
Observation 1: "Design validation did not ensure the device conforms to defined user needs and intended uses."
Essentially, the FDA investigators came to the conclusion that as it is now, the proof that the device is doing what it's supposed to isn't strong enough.
Observation 2: "The design was not validated under actual or simulated use conditions."
Here, the FDA is elaborating on its first observation. The technology Theranos is using in its labs, the FDA notes, isn't numbered and listed the way it should be under FDA regulations.
Observation 3: Design input requirements were not adquately documented.
Here, the FDA digs into Theranos' use of TSCDs, or Terumo sterile tubing welders, which are used in the lab as part of the blood testing process.
Business Insider is continuing to learn more about the recently released documents. We will continue to update this post as more information comes in.