The Food and Drug Administration just posted its lab inspection reports for Theranos, the much-hyped blood testing startup that has been facing sharp questions about whether its technology actually works.
The documents are heavily redacted, but it seems the FDA took issue with the company's failure to properly validate its technology:
The FDA inspectors, who reviewed Theranos' facilities in Newark and Palo Alto, California in August and September, recorded a number of documentation and quality-control failures.
They determined that Theranos's collection containers — known as "nanotainers" — are "uncleared medical devices", since they were not approved by regulators under the proper medical device classification.
The FDA also notes that Theranos failed to respond to customer complaints, and did not set up an adequate procedure for reviewing complaints that come into the lab:
The FDA also wasn't happy with the company's quality-assurance processes. In particular, Theranos didn't seem to look into whether the suppliers it relied on actually met the company's quality requirements.
In response to the FDA documents, Theranos sent this comment, claiming that they've fixed the problems outlined by FDA inspectors and that they continue to work with the regulator as they seek full approval for their tests and technology:
We believe that we addressed and corrected all the observations at the time of, or within a week of, the inspection and have submitted documents to FDA that say so, including extensive documentation, as well as outlining our path to the whole QSR transition going forward. Their observations are, by their very nature, preliminary and in this is a time of evolving policy, we have advocated for the transition from the LDT framework to the FDA quality systems framework.
You can read the entire (heavily redacted) reports here and here. The reports were posted in response to a Freedom of Information Act request.
These reports, known as a Form 483, are issued by FDA investigators to inform company management of "objectionable conditions" in medical labs.
Specifically, the FDA looks for violations of the Food, Drug, and Cosmetic Act to see if "conditions or practices observed would indicate that any food, drug, device, or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health."