FDA Details Theranos Deficiencies in Two Form 483s

Chief Executive Elizabeth Holmes, a Silicon Valley darling, fought back strongly, saying her company’s technology was sound.

The FDA’s investigation was carried out between August 25 and September 16 and raises questions about Theranos’ quality control.

And unlike the other eight observations, which FDA says Theranos has promised to correct within seven days, this observation on the classification of the CTN is still “under consideration”.

The healthcare startup has obtained FDA nod to sell blood tests for the notorious sexually transmitted herpes simplex virus. Among them, Theranos didn’t investigate whether the suppliers of materials it used had met the company’s quality requirements, according to one of the reports.

“We are charting new pathways, and are working to create a model for the transition”, Theranos said.

Another Form 483, addressed to Theranos COO Ramesh Balwani, chastises the company for marketing its product, which is manufactured and used by Theranos to collect blood samples, as an unapproved medical device.

The FDA has said that Theranos’ “nanotainers” are actually “uncleared medical devices” that are being wrongfully shipped across state lines. These nanotainers, to be clear, are the tiny vials pictured above that Theranos has built its reputation around.

The FDA also said that quality audits had not been performed at the facility. The drug store chain now offers Theranos testing at 41 stores in Arizona and California, but has “no concrete plans” to expand the relationship, a Walgreens official told the WSJ. More than 120 of the tests developed for use on Theranos’s devices have been pre- submitted to the FDA to gain the agency’s guidance on product development or application preparation, Theranos said. Theranos has disputed the article’s claims, and the Journal has said it stands behind the story.

FDA also listed inspection observations that many startup testing companies unfamiliar with USA regulations get slapped on the hand for, including inadequate procedures for evaluating complaints and documenting corrective actions.