Medica Outlet - 06/01/2015
- Medica Outlet
- Issuing Office:
- Center for Devices and Radiological Health
Department of Health and Human Services
|Food and Drug Administration|
10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993
June 01, 2015
Toronto Eaton Centre
1 Dundas Street West, 2601
Toronto, ON M5G1Z3
Email address: firstname.lastname@example.org
Re: Dermal Fillers comprised of Hyaluronic Acid (Teosyal)
To the Proprietors of www.medicaoutlet.com:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing various dermal fillers in the United States 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). these product 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 any function of the body.
FDA has reviewed the website, www.medicaoutlet.com and determined that various formulations of Teosyal are being marketed as a hyaluronic acid based dermal filler used, for example, to treat wrinkles, add contour to facial features, enhance the lips, and to eliminate the appearance of aging.
A review of our records reveals that your firm has not received clearance or approval before offering its devices for sale in the US, which is a violation of the law. Therefore, the line of Teosyal products 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 approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for 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) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce these devices into commercial distribution, as required by section 510(k) of tihe 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 devices 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 products may be legally marketed.
Given the serious nature of the violations of the Act, the dermal fillers marketed by your firm are subject to refusal of admission under section 801 (a) of the Act, 21 U.S.C. § 381 (a), in that they appear adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter.
Please notify this office in writing within fifteen (15) 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) 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:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Inspections Support Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the identification number CMS 460334 when replying. We remind you that only written communication is considered official. If you have any questions about the contents of this letter, please contact: LaShanda M. Long at 301-796-5465 or 301-847-8137 (fax).
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.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and