Home / Technology / F.D.A. Cites Unapproved Device in Theranos Review, and Faults Handling of Complaints

F.D.A. Cites Unapproved Device in Theranos Review, and Faults Handling of Complaints

Inspectors from the Food and Drug Administration have found various deficiencies in the quality control procedures of the closely watched medical testing company Theranos, according to documents released by the federal agency on Tuesday.

Among 14 “observations” listed in two inspection reports, the agency said that Theranos had not established adequate procedures for following up on customer complaints.

“Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary,” one of the reports said.

It pointed out a specific instance involving the tiny tubes the company used to collect blood. It said a report about a possible difficulty in clearly seeing the clotting of blood was not recorded or investigated as a complaint.

Theranos did not have an immediate comment Tuesday morning but was planning to respond as soon as possible, a spokeswoman said.

Theranos has gained wide attention because of its claim to be able to perform numerous medical tests quickly and inexpensively using a tiny sample of blood from a finger prick, rather than tubes of blood drawn from the arm. Its founder and chief executive, Elizabeth Holmes, who dropped out of Stanford and is now a billionaire, has become a Silicon Valley celebrity.

But recently questions have been raised about how well the company’s testing technology works and how much the company is actually using its own technology, as opposed to standard equipment. On Monday, at a conference hosted by Cleveland Clinic, which has a partnership with Theranos, Ms. Holmes responded to critics by agreeing to publish data showing its tests are accurate.

The F.D.A. inspected Theranos from late August through mid-September. The inspections apparently followed the F.D.A.’s approval of one of the company’s tests, for herpes simplex 1 virus, over the summer.

The agency released on its website two Form 483 reports, which are routinely issued after inspections. It is not uncommon for the agency to find problems during an inspection.

Both inspection reports are heavily redacted, making them difficult to interpret. The observations in general are about gaps in the company’s quality assurance procedures and documentation, as opposed to specific problems with its machinery and tests.

Theranos either corrected or promised to correct the problems, according to the inspection reports, though the F.D.A. noted it had not confirmed that the corrections had been made.

The inspectors pointed out that the company’s tiny blood collection tube, the “nanotainer,” was a medical device that had not been cleared by the agency but was being shipped in interstate commerce.

Theranos said earlier this month that it had stopped using the nanotainer for all but the herpes test until it could obtain F.D.A. clearance. While Ms. Holmes has at times said this was a voluntary move, it does appear from the inspection report that there was explicit pressure from the F.D.A.

One of the reports said the company undertook corrections of its quality management system procedures and records without documenting the investigations into the causes of the problems and actions needed to prevent recurrences. It also said the company had not performed audits of its quality management system.

It noted that during the inspection, Theranos was unable to produce documentation that its suppliers met qualifications. Yet the company had purchased supplies used in manufacturing the nanotainers from such vendors, the report said.


NYT > Technology

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