Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm450092.htm
Timestamp: 2019-04-26 04:16:24+00:00

Document:
During an inspection of your firm located in Bothell, Washington, on February 5, 2015, through February 25, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the TAP® 3 TL and Elite TL anti-snoring/obstructive sleep apnea devices and the Silent Partner anti-snoring/obstructive sleep apnea device. 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 procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, no corrective and preventive action procedures were available for review upon request by the investigator. You indicated your firm has not established corrective and preventive action procedures.
We reviewed your firm’s response and conclude that it is not adequate. Your response included a Silent Partner Device History and Performance Summary Policy and a TAP 3TL and TAP Elite Device History and Performance Summary Policy, which both describe your corrective action and preventative action processes. It is not clear how you determined that (b)(4) or more complaints similar in nature within a (b)(4) month period is an appropriate statistical methodology to detect recurring quality problems, as described in 21 CFR 820.100(a)(1). The corrective action and preventative action processes did not describe procedures for verifying or validating the corrective and preventive action, as described in 21 CFR 820.100(a)(4). The corrective action and preventative action processes did not account for analyzing sources of quality data other than complaints, as described in 21 CFR 820.100(a)(1). The corrective action and preventative action processes did not describe whether relevant information on identified quality problems, as well as corrective and preventive actions, would be provided for management review, as described in 21 CFR 820.100(a)(7).
2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, no complaint handling procedures were available for review upon request by the investigator. You indicated that your firm has not established complaint handling procedures. Complaint documentation also did not include documented evaluations of the complaints.
We reviewed your firm’s response and conclude that it is not adequate. You stated a new QMS policy would be established by the week of March 16, 2015. Your response included a draft Additions to QMS master policy document, TAP Appliance History Log, Silent Partner Appliance History Log, Silent Partner Occurrence Log, TAP 3TL and Elite Partner Occurrence Log and the Product Complaint/Corrective Action Log. Your response also included a Silent Partner Device History and Performance Summary Policy and TAP 3TL and TAP Elite Device History and Performance Summary Policy. These documents did not formally designate a unit for receiving, reviewing, and evaluating complaints, as described in 21 CFR 820.198(a). It was unclear whether complaints apply to all returned work and when the Occurrence Log and Product Complaint/Corrective Action Log would be completed.
a. Your firm did not maintain documentation of the evaluation and selection of suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 CFR 820.50(a)(1).
b. Your firm did not maintain purchasing documents that include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device, as required by 21 CFR 820.50(b).
We reviewed your firm’s response and conclude that it is not adequate. Your response indicates that, at the time your response was submitted to FDA for review, you had taken no action to correct this violation, and your response did not indicate whether interim actions would be taken while corrective actions are in progress. Your response did not indicate a proposed timeframe for corrective actions.
a. The dated signature of the individual authorizing the release of the device.
b. The acceptance activities performed that are identified in the fabrication techniques and/or manufacturing procedures.
No procedures covering finished device acceptance were available for review upon request by the investigator. You indicated that your firm has not established procedures covering finished device acceptance.
We reviewed your response and conclude that it is not adequate. Your response included a TAP Appliance History Log and Silent Partner Appliance History Log; however, it is unclear whether the list of quality control criteria within these logs represents finished device acceptance criteria. Your response included the Silent Partner Device History and Performance Summary Policy, and TAP 3TL and TAP Elite Device History and Performance Summary Policy, which describe the device history log. It is unclear whether these documents represent a procedure for finished device acceptance.
5. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, no procedure addressing the control and disposition of nonconforming product was available for review upon request by the investigator. You indicated that your firm has not established a procedure addressing the control and disposition of nonconforming product.
We reviewed your response and conclude that it is not adequate. Your response included a draft Additions to QMS master policy document and stated a new set of forms would be developed by the end of March 2015. Your response did not indicate whether interim actions would be taken while the corrective action is in progress. Your draft procedure did not address the evaluation, segregation, and disposition of non-conforming product, as described in 21 CFR 820.90(a). The evaluation of nonconformance must be conducted and the evaluation and any resulting investigation must be documented, as described in 820.90(a).
6. Failure to establish procedures for quality audits and failure to conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, no procedures for quality audits were available for review upon request by the investigator. You indicated that your firm has not established a quality audit procedure and no quality audits have been completed.
We reviewed your firm’s response and conclude that it is not adequate. Your response indicates that, at the time your response was submitted to FDA for review, you had taken no action to correct this violation and intend to create and implement quality audits in May 2015. Your response did not indicate whether interim actions would be taken while the corrective action is in progress.
7. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. For example, no document control procedures were available for review upon request by the investigator. You indicated that your firm has not established document control procedures.
We reviewed your firm’s response and conclude that it is not adequate. Your response references a written policy that was provided during the inspection, but does not specify the title of this policy.
8. Failure to develop, maintain and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, no Medical Device Reporting procedure was available for review upon request by the investigator. You indicated that your firm has not established written MDR procedures.
We reviewed your firm’s response and conclude that it is not adequate. Your response included a draft Additions to QMS master policy document which does not address electronic submission of MDRs. The document does not address a standardized review process or procedure for determining when an event meets the criteria for reporting, as described in 21 CFR 803.17(a)(2). Your response does not indicate whether interim actions would be taken while the corrective action is in progress.
The electronic Medical Device Report (eMDR) Final Rule requiring manufacturers and importers to submit electronic MDRs to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm. If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the MDR Policy Branch at 301-796-6670 or by e-mail at MDRPolicy@fda.hhs.gov.
Our inspection also revealed that the TAP® 3 TL and Elite TL anti-snoring/obstructive sleep apnea devices, for which you manufacture under a licensing agreement and commercially distribute to your own customers, are 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 devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 350(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) of the Act, 21 U.S.C. § 360(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.
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 systematic 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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. Refer to the WL SEA 15-18 when replying. If you have any questions about the content of this letter, please contact: Compliance Officer Katherine L. Arnold at 425-302-0437.

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