Nanhai Meishida Beauty Equipment Co., LTD 3/1/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
March 1, 2013
VIA UNITED PARCEL SERVICE
Mr. Guoxiang He
Nanhai Meishida Beauty Equipment Co., LTD
NO. 5th Liangui Road Industrial District
Yanbu Town, Nanhai, Foshan City, China
Dear Mr. He:
During an inspection of your firm located in Foshan City, China, on September 10, 2012, through September 13, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Model M-2040, 13 in 1 Beauty Instrument. 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 function of the body.
Our inspection revealed that your firm’s 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. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
For example, during the inspection that occurred from September 10, 2012 through September 13, 2012, your firm stated that it does not have a written procedure that dictates how and when to submit a Medical Device Report to FDA.
We reviewed your firm’s response, dated October 5, 2012, and concluded that it is not adequate. Although your firm provided a copy of an MDR procedure and an updated complaint handling procedure, your firm did not address whether its employees have been trained on and implemented the new procedures.
Additionally, the procedures were submitted to FDA in a language other than English, therefore the adequacy of the procedures could not be determined.
Additionally, during our inspection the investigator reviewed a user’s manual for the Model M-2040, 13 in 1 Beauty Instrument. According to your firm’s user manual, "High-frequency function" is based on the principle of "treatment on skin adopting high frequency current between 150 ~ 200 KHz together with high frequency bar." The purported effects of this high-frequency function include:
- "sterilization and evaporation," in which the "ultraviolet radiation generated by high frequency bar produces effects of many bacteria of human body. High frequency accelerates evaporation and desiccation of skin surface. When the high frequency bar touches [the] skin, it makes effect on leaking fat skin and dander."
- "hyperemization," in which the "vacuum high frequency bar generates effect on the hair by activating skin surface, expanding blood vessel, accelerating blood circulation and increasing oxygen combination of skin."
Additionally, the user’s manual states that there is a "galvanic function" that utilizes "bioelectricity leading in," in which "stimulated by current drives freshly active substance into the affected part to speed up metabolization" and "nutrition in" / "hydronium leading in," in which "hydronium [i.e. water ions] is driven by the current to enter into skin internal for absorption of muscle and skin.”
A review of our records reveals that your firm did not obtain marketing approval or clearance for these devices. Therefore, the Model M-2040, 13 in 1 Beauty Instrument, 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). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(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) 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 of 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.
Given the serious nature of the violations of the Act, Model M-2040, 13 in 1 Beauty Instruments manufactured 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 products 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. We will notify you if your firm’s response appears to be adequate, and we may need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, U.S. 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, including 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. Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 391205 when replying. If you have any questions about the contents of this letter, please contact: LaShanda Long at 301-796-5465 or fax to 301-847-8137.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.
Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and
8301 Valdez Ave Ste 100
Sacramento, TX 95828