FDA warns a Canadian device manufacturing company

DNA Genotek, a Canadian diagnostics manufacturer recently received a warning Letter from the USFDA. The warning letter focuses on the Ottawa, Canada facility of the company and is related to the manufacturing of two of its devices. The two devices in discussion are The Oragene Dx, which is popular as a DNA collection kit for testing samples and the ORAcollect (OC-100), which uses human oral samples such as cheek swabs. The devices are aimed at facilitating the collection and transportation off the DNA samples intended for testing. These kits themselves do not diagnose any condition.

The health regulator alleged and stated that the company's products are considered as adulterated. There is also a mention of an instance that the company has marketed products without having received prior approval from the agency. It also aims at stating that the company has failed to implement the desired quality systems in various areas. FDA alleged that ORA collect was marketed without prior approval while the regulators were unhappy with the Oragene Dx device as it neither included design and development plan nor the mention that it was in accordance with the applicable regulations.

The company takes this warning letter seriously and aims to resolve the issues as early as possible.