NINGBO LINGGUANG ELECTRIC APPLIANCE CO., LTD. 7/1/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire A venue|
Silver Spring, MD 20993
July 1, 2013
Via United Parcel Service
Mr. H. Chase Lenfest, Chairman
Lenfest Media Group, LLC
500 North Gulph Road
King of Prussia Pennsylvania 19406
Refer to CPT1200584 when replying to this letter.
Dear Mr. Lenfest:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the WaxVac device in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is 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 function of the body.
The FDA has reviewed your firm’s internet web site at: https://www.waxvac.com/ for the WaxVac device. Your firm’s promotion of the WaxVac contains claims for which your firm lacks clearance or approval. Examples include: “Gently draws dirt particles and moisture out of your ear quickly and safely”.
The WaxVac 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).
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 C.F.R. 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.
Our office requests that Lenfest Media Group, LLC. immediately cease activities that result in the misbranding or adulteration of the WaxVac, such as the commercial distribution of the device for the uses discussed above.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, 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.
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 (including any systemic corrective actions) 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: Ronald L. Swann, Office of Compliance, Food and Drug Administration, 10903 New Hampshire Avenue, WO66-room3534, Silver Spring, MD 20993, facsimile at (301) 847-8137. Refer to the identification number CPT1200584 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Ronald Swann at (301) 796-5469.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
Steven D. Silverman
Office of Compliance
Center for Devices and