Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449545.htm
Timestamp: 2019-04-25 14:03:26+00:00

Document:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing hyaluronic acid gel 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 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 any function of the body.
The FDA has reviewed the website, www.beautycosmeticstore.com, and determined that hyaluronic acid gel is being marketed as dermal fillers used for the treatment of wrinkles and lip augmentation (Dermafil), and additionally for buttocks and breast augmentation (hereinafter referred to as Hyaluronic Acid Gel Products).
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 Hyaluronic Acid Gel 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 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) 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 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 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 Hyaluronic Acid Gel Products 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 to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, your firm 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) 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.
Refer to the identification number CMS 460153 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 1-301-796-5465 or 1-301-847-8137 (fax).

References: § 321
 § 351
 § 360
 § 360
 § 352
 § 360
 § 381