Inspections, Compliance, Enforcement, and Criminal Investigations
Dr. Steven K. Sue, D.D.S., M.S., Inc. 31-Oct-06
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL EXPRESS
October 31, 2006
Dr. Steven K. Sue, D.D.S.; M.S., INC.
dba Nose Breathe
2065 S King Street, Suite 304
Honolulu, Hawaii 96826-2225
Dear Dr. Sue:
During an inspection of your firm located in Honolulu, Hawaii on July 25, 2006 through August 9,'2006, an investigator from the United States Food and Drug Administration(FDA) determined that your firm manufactures the Nose Breathe Mouthpiece, Nose Breathe for Heavy Snorer, Nose Breathe Pacifier and Nose Breathe Tongue Positioner. Under section 20l(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 are intended to affect the structure or function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in; 6r the facilities or controls used for, their manufacture, packing, storage or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation .found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but, are not limited to, the following:
1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(2).
For example, your firm did not implement adequate design controls to ensure that specified design requirements were met.
2. Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementations, as required by 21 CFR 820.30(b).
For example, there were no written plans that describe or reference design and development activities for class II devices in commercial distribution.
3. Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient, as required by 21 CFR 820.30(c).
For example, your firm has no written design requirement procedures for any of the NoseBreathe devices.
4. Failure to establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements, as required by 21 CFR 820.30(d).
For example, your firm does not have written procedures that define and document design output or identify acceptance criteria for the devices.
5. Failure to establish and maintain procedure for verifying the device design, as required by 21 CFR 820.30(f).
For example, there are no written procedures to verify the device design and no documentation to demonstrate verification activities for the devices.
6. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g).
For example, your firm does not have documented validation activities to demonstrate that the devices conform to define user needs and intended uses.
7. Failure to adequately establish and maintain procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h).
For example, your firm does not have written procedures to ensure the device design has been translated into production specifications.
8. Failure to establish and maintain a Device History File (DHF) for each type of device, as required by 21 CFR 820.30(j).
For example, your firm failed to have a DHF for each device.
9. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a).
For example, there are no process controls to ensure the device conform to specifications. Your firm failed to identify production specifications for the Nose Breathe and Nose Breathe for Heavy Snorer.
10. Failure to establish and maintain procedures and records for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d).
For example, your firm does not have established procedures for acceptance and rejection of finished devices and has no documentation of acceptance activities.
11. 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, during our inspection, you informed the investigator that you [redacted]. Our investigator requested the review of the documents, but none was available. You have not established a procedure to address the identification, documentation, evaluation, segregation, and disposition of nonconforming products as required.
12. Failure to establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product, as required by 21 CFR 920.90(b)(1).
For example, there are no written procedures or documentation for non-conforming product. You [redacted] devices that are not within the required specifications.
13. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
For example, your firm does not have established procedures for implementing corrective and preventive actions and does not document corrective or preventive actions.
14. Failure to adequately 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, your firm does not have written complaint handling procedures.
15. Failure to determine whether the complaint represents an event which is required to, be reported to FDA under part 803 or 804 of this chapter, Medical Device Reporting, as required by 21 CFR 820.198(a)(3).
For example, there was not enough information documented to determine if a complaint is a reportable event.
16. Failure to review and evaluate all complaints to determine whether an investigation is necessary, as required by 21 CFR 820.198(b).
For example, your firm did not have records of an investigation into any complaints.
Our inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation.
Our inspection further revealed that the Nose Breathe Mouthpiece, the Nose Breathe for Heavy Snorers, the Nose Breath Pacificer and the Nose Breathe Tongue Positioner are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 35l(f)(1)(B), and misbranded under section 502(o) of the Act because you are promoting them for new intended uses for which approval or clearance from the FDA has not been obtained.
You received clearance from the FDA to market the Nose Breathe Mouthpiece for Heavy Snorer (K013687). According to our records, that device was cleared to "reduce snoring by placing the tongt1e forward to the roof of the mouth." However, our recent review of your internet website, www.nose breathe:com, revealed that you are promoting your devices for several additional intended uses, including:
Solutions for nasal congestion, watery and itchy eyes, runny nose, allergies, dry cough, tongue thrust, abnormal swallowing habits, crooked teeth, low energy level, and asthma;
Enhancement of respiratory systems;
Treatment of mild apnea; and
Solution for earaches.
As described above, your devices are therefore adulterated under section 501(f)(1)(B) of the Act because you do 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 (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your 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 you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Lawton W. Lum, Compliance Officer, United States Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502, at 510-337-6792, Fax # 510-337-6706.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations. Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Barbara J. Cassens
San Francisco District