Regulatory Focus™ > News Articles > FDA Details Theranos Deficiencies in Two Form 483s

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Posted 27 October 2015 | By Zachary Brennan 

FDA Details Theranos Deficiencies in Two Form 483s

The heavily-redacted Form 483s released by the US Food and Drug Administration (FDA) on Tuesday for the blood testing company Theranos include 14 observations, with several on device design, classification and on how the company deals with complaints.

Most recently, the highly-valuated Theranos has come under fire following a Wall Street Journal investigation that raised a number of questions about the accuracy of the company's proprietary blood testing technology and how the company is operating.

Form 483s

The Form 483s are linked to an FDA inspection of Theranos' two facilities in Newark and Palo Alto, California from 28 August to 16 September.

For the Newark site, FDA included nine observations, including one on the company's proprietary blood specimen collection device, known as the Capillary Tube Nanotainer (CTN), which FDA says is a Class II device, though Theranos had claimed it was a Class I exempt device and it was shipping it between California, Arizona and Pennsylvania.

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."

FDA also raised concerns about the procedures for how Theranos receives, reviews and evaluates complaints about its products.

Specifically, FDA found that one of Theranos' complaint logs provided to FDA "contained no logged complaints," though a different log included complaints. FDA notes one specific complaint on "CTN specimen quality" that Theranos "did not investigate" as a complaint.

Under a section on quality management systems, FDA also called out Theranos for failing "to produce documented supplier qualifications."

Theranos also didn't investigate "the probable cause for not having supplier qualification documentation, or to investigate if these suppliers met your quality requirements" while purchasing materials from them.

In addition, FDA found Theranos failed to document software validation activities, particularly around the use of an unvalidated Excel spreadsheet.

The other Form 483 for the Palo Alto site included five observations, all of which Theranos reported corrected, but which have not been yet verified. The observations are linked to design validation, design risk analysis and failing to review and approve certain documents by designated individuals.

FDA Form 483 for Newark, California

FDA Form 483 for Palo Alto, California


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