Canadian diagnostics manufacturer DNA Genotek is the recipient of a Warning Letter from the US Food and Drug Administration (FDA) alleging that the company's products are adulterated and, in one case, being marketed without prior approval or clearance, the agency announced this week.

QSR Problems

The Warning Letter, released 7 January 2014, references DNA Genotek's Ottawa, Canada, facility and its manufacture of two devices: The Oragene Dx and the ORAcollect (OC-100). The Oragene Dx device is marketed as a DNA collection kit for samples intended for diagnosis, while the ORAcollect is used for "human oral samples" like cheek swabs. The devices do not themselves diagnose any condition, but instead facilitate the collection, stabilization and transportation of DNA samples.

But as the Warning Letter alleges, DNA Genotek failed to properly implement numerous elements of the Quality System Regulation under 21 CFR 820.

For example, regulators wrote that they were unimpressed by the company's product design documentation, which did not include a "design and development plan for the Oragene Dx device." Similarly, the device history file for the same device did "not include or reference the records to demonstrate that a design and development plan was developed in accordance [with federal regulations]," FDA wrote.

The ORAcollect device also ran into trouble during the inspection, with investigators claiming they were unable to find a written procedure for one part of the device's finished device acceptance process.

Lacking Approval

But perhaps more problematic for the company was FDA's finding that ORAcollect was adulterated by virtue of lacking an approval application for premarket approval (PMA) under section 515(a) of the Federal Food, Drug and Cosmetic Act (FD&C Act) or a premarket notification under section 510(k).

In a statement, OraSure Technologies, the parent company of DNA Genotek, said it was "actively engaged and working with the FDA to address the agency's observations and will continue to sell and market all of its products while responding to the Warning Letter." It is unclear how the company would continue marketing the ORAcollect device given FDA's claims that it is both adulterated and misbranded, but the company said the device made up a fraction of a percentage of its revenues.

"We take this letter from the FDA very seriously and we are working closely with the agency to ensure we fully address their concerns and observations," said Douglas Michels, president and CEO of OraSure Technologies. "We are committed to providing the highest quality products to our customers and to continuously enhancing our systems and processes."

OraSure Statement

Warning Letter