DNA Genotek Inc. – FDA Warning Letter, Sep 20, 2013

An FDA inspection of DNA Genotek, Inc. in Ottawa, Canada, from September 16-20, 2013, revealed that the firm's Oragene Dx and OC-100 devices are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. This is due to non-conformity with the Quality System (QS) regulation (21 CFR Part 820). Specific QS violations include the failure to establish and maintain design and development plans (21 CFR 820.30(b)) and a Design History File (DHF) (21 CFR 820.30(j)) for the Oragene Dx device. Additionally, the firm failed to establish adequate procedures for finished device acceptance for the OC-100 device. The FDA deemed the firm's October 10, 2013, response inadequate, citing a lack of documentation for employee training, implemented corrections, and systemic corrective actions, including retrospective reviews. Furthermore, the OC-100 device was found to be adulterated under section 501(f)(1)(B) for lacking an approved premarket approval (PMA) or investigational device exemption (IDE), and misbranded under section 502(o) for failing to submit a 510(k) premarket notification. The firm must respond within fifteen business days detailing specific, systemic corrective actions, including documentation and a timetable. Failure to correct these violations may impact federal contracts, PMA approvals, and Certificates to Foreign Governments.