Source: https://www.casewatch.net/fdawarning/prod/2013/dna_genotek.shtml
Timestamp: 2019-04-26 02:39:21+00:00

Document:
During an inspection of your firm located in Ottawa, Canada on September 16, 2013 through September 20, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Oragene Dx and OC-100 devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
1. Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation, as required by 21 CFR 820.30(b).
For example: New Product Information, QP-007 does not describe how the design project will be planned, requirements for design planning and who is responsible for the design and development planning activities. The firm did not provide the design and development plan for the Oragene Dx device.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a copy of the revised SOP QP-007 New Product Information that includes the requirements for design and development planning for the Oragene DX device. However, your firm did not provide documentation that employees were trained on these new procedures, that a correction and corrective action were implemented and that a systemic corrective action was considered to include a retrospective review of design and development planning activities for other devices.
2. Failure to establish and maintain a DHF for each type of device that contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part, as required by 21 CFR 820.30(j).
For example, the Design History File for the Oragene Dx device does not include or reference the records to demonstrate that a design and development plan was developed in accordance with requirements of 21 CFR 820.30.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a copy of the revised SOP QP-007 New Product Information that lists the requirements for how design and development planning will be captured in the Design History File. However, your firm did not provide documentation that employees were trained on these procedures and that the Design History File for the Oragene Dx device included or referenced records to demonstrate that a design and development plan was completed. Your firm did not provide documentation that a correction and corrective action were implemented and that a systemic corrective action was considered to include a retrospective review of the Design History File for other devices.
3. Failure to establish and maintain adequate procedures to include information for finished device acceptance to ensure that each production run, lot, or batch of the OC-100 device meets acceptance criteria.
For example, there is no written procedure for the (b)(4) for the OC-100 product.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a copy of the SOP PD-WI-00012 issue 1 that lists the requirements for how the measurement of the (b)(4) and the acceptance criteria. However, your firm did not provide documentation that employees were trained on these procedures, that a correction and corrective action were implemented and that a systemic corrective action was considered to include a retrospective review of final acceptance activities for other device lots and other devices.
Our inspection also revealed that the OC-100 is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #416225 when replying. If you have any questions about the contents of this letter, please contact: Ileana Elder at 301-796-6143 or via fax at 301-847-8514.

References: § 321
 § 351
 § 360
 § 360
 § 352
 § 360