The Food and Drug Administration released inspection documents Tuesday that are critical of lab startup Theranos' device classifications, internal recordkeeping and lab protocols.
Among other issues, the heavily redacted documents accuse Theranos of misclassifying its proprietary “Nanotainer” that purportedly only require a few drops of blood for lab samples. A series of articles in the Wall Street Journal have accused the company of failing to use the tiny container and its Edison proprietary technology for most of its tests.
The reports, from inspections that took place between Aug. 25 and Sept. 16 of this year, were released after multiple Freedom of Information Act Requests, an FDA spokeswoman said. The spokeswoman was looking into whether the department can comment further.
Theranos responded to the release of the FDA forms in an extensive, jargon-heavy statement Tuesday afternoon, maintaining that it believes it has “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.” The company said the inspections came after it had received clearance for its proprietary lab devices, software and Nanotainer tubes.
The startup reiterated that it has since decided to “pause” its use of Nanotainers for all but one test as it brings its labs up to speed with FDA medical device regulations, which are different from CMS regulations regarding clinical labs that Theranos has so far been working under.
“We are in close contact with FDA in this process,” Theranos said. The company said its “technology is much more than the Nanotainer tube. Our proprietary systems and technologies – which we protect as intellectual property – have been rigorously tested and reviewed.”
The FDA said the Nanotainer is currently classified by Theranos as a Class I exempt medical device but should be classified as a Class II medical device, because it is used to collect blood specimens. The Journal previously cited an anonymous source who said the FDA had showed up unannounced at Theranos labs and had indicated that the container was an unapproved medical device.
Theranos was also failing to properly track and respond to customer complaints, the reports said. The company's internal recordkeeping regarding quality assurance, container manufacturing, software validation and suppliers is also not up to regulatory standards, the FDA said.
Also, the company has not been conducting internal audits of its quality management system and has failed to provide qualifications for a number of suppliers, according to the report.
The FDA hasn't verified any correct actions, according to the reports, but Theranos did report several as corrected or promised to correct them within seven days. The form was issued Sept. 16.
The reports, known as Form FDA-483, are issued to management after an inspection to denote any potential violations of the Food Drug and Cosmetic Act and other FDA-related laws.