Inspections, Compliance, Enforcement, and Criminal Investigations
GC America, Inc. 11/21/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
November 21, 2012
VIA UPS NEXT DAY
Mr. Yutaka Suzuki
GC America, Inc.
3737 W. 127th Street
Alsip, Illinois 60803
Dear Mr. Suzuki:
During an inspection of your firm located in Alsip, Illinois, on June 27, 2012, through July 13, 2012, the Food and Drug Administration (FDA) determined that your firm is marketing the MI Paste, MI Paste Plus, and MI Varnish devices in the United States without appropriate marketing approval, in violation of the Federal Food, Drug and Cosmetic Act (the Act). These products are devices within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), 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 any function of the body.
Your firm obtained clearance of the MI Paste (K042200) on October 20, 2004, MI Paste Plus (K070854) on April 12, 2007, and the MI Varnish (K102808) devices on December 22, 2010, under Section 510(k) of the Act, 21 U.S.C. § 360(k). Both the MI Paste and MI Paste Plus devices are cleared for prescription use for the following indications: “to be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment. Secondarily, for the management of tooth sensitivity, ultrasonic, post scaling, root planning and bleaching.” Additionally, MI Paste Plus is cleared for the following indication: “to relieve dental hypersensitivity.” The MI Varnish is cleared for prescription use as “a fluoride varnish with Recaldent (b)(4) that has a desensitizing action when applied to tooth surfaces.”
Our review of MI Paste, MI Paste Plus, and MI Varnish product brochures and indications pads found that your firm is making additional disease and structure/function claims for these devices that represent expansions in their intended uses, which are outside the products’ 510(k) clearance. These claims represent major changes or modifications in the cleared intended use of these devices, under 21 CFR 807.81(a)(3)(ii).
Examples of these claims include, but are not limited to:
• Remineralization claims [MI Paste, MI Paste Plus and MI Varnish]
• Treating dry mouth (xerostomia) [MI Paste, MI Paste Plus]
• Treating Sjogrens syndrome [MI Paste, MI Paste Plus]
• Penetrating and remineralizing sub-surface lesion [MI Paste, MI Paste Plus]
Based on these additional claims, the MI Paste, MI Paste Plus, and MI Varnish devices 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 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).
Furthermore, the MI Paste, MI Paste Plus and MI Varnish devices are misbranded under Section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the FDA of its intent to introduce these devices into commercial distribution with the new intended uses described above, as required by Section 510(k) of the Act, 21 U.S.C. § 360(k). For devices 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 FDA, as required by 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval for the device is described on the FDA website 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 these devices may be legally marketed.
The FDA requests that GC America, Inc. immediately cease marketing and disseminating labeling and promotional materials for the MI Paste, MI Paste Plus, and MI Varnish devices bearing claims such as those described above. Your firm may not market the devices for any intended use that is outside its section 510(k) clearance unless it has first obtained appropriate marketing authorization.
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.
If you have any questions about the contents of this letter, please contact: Carrie Ann Plucinski, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS case # 353579) when replying. If you have any questions about the content of this letter, please contact Ms. Plucinski at 312-596-4224.
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. 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.
Scott J. MacIntire