Theranos, a hot startup that recently received media scrutiny regarding its testing system, has been hit with two 483s, one of which takes the company to task for shipping an uncleared device.

During an Aug. 25 to Sept. 16 inspection of Theranos facilities in Newark, Calif., an FDA representative determined that the company improperly identified its Capillary Tube Nanotainer, a blood specimen collection device, as Class I exempt. It should be listed as Class II, according to the 483.

In addition, the FDA dings the company for not having a formal unit in place for receiving, reviewing and evaluating complaints. Its two written procedures don’t accurately describe the entire complaint handling procedure. Further, its written procedures do not match those verbally described during the inspection.

The investigator also observed that complaints involving possible failure of a device were not investigated properly. It cites a complaint that says parts of a component were too opaque to see clotting clearly. According to the 483, the company neither identified nor investigated this as a complaint. It also did not confirm whether it needed to file an MDR.

The facility also is taken to task for not documenting corrective and preventive action activities. It made several corrections to its quality management system procedures without documenting and investigating the causes of nonconformities.

“For example, during this inspection, you were unable to produce documented supplier qualifications, and you corrected the deficiency by assembling the required supplier qualification documents for your suppliers,” the 483 stated. The company undertook this action, however, without opening a CAPA to determine the possible cause for not having supplier qualification documentation. Further, it failed to determine whether suppliers had met quality requirements for the entire time they had done business with Theranos.

The company also is dinged for failure to: Document software validation activities, establish records of acceptable suppliers, have procedures for device history records or perform quality audits.

In a statement, Theranos says it has been building quality systems. “Theranos had voluntarily begun transitioning from the CLIA laboratory quality systems to FDA quality systems throughout 2014,” the statement adds.

Palo Alto 483

The company also received a 483 for an inspection at its Palo Alto facility that is heavily redacted. It hits the company over its design validation, which didn’t ensure the device conformed to defined user needs and intended uses. In addition, the design was not validated under actual or simulated use conditions, neither design input requirements nor results of the design risk analysis were adequately documented and documents were not reviewed or approved by a designated individual prior to issuance.

Word of the 483s came days after news reports questioned whether Theranos’ device, dubbed Edison, could be used in all of the tests the company claimed. It also questioned the test’s accuracy.

The company hit back against the allegations. “We are confident in the reliability of our tests, because we comprehensively validate the accuracy of every test we run,” the company says.

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