Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm437429.htm
Timestamp: 2019-01-23 07:56:13
Document Index: 675329033

Matched Legal Cases: ['§ 321', '§ 351', '§ 360', '§ 360', '§ 352', '§ 360', '§ 352', '§ 360', '§ 360', '§ 360']

Winter Goals 3/5/15
W/L # 11-15
Ms. Cheri DeShaw, Owner
753 N. Main St. Ste D-2
Cottonwood, AZ 86326-3612
Dear Ms. DeShaw:
During an inspection of your firm located in Cottonwood, Arizona, conducted on January 24, 2014 and on February 12, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Energetic Test Kits aka Alternative Cancer Treatment Test Kit aka The Muscle Test Kit (Kinesiology) [hereafter noted as “Test Kits”]. In addition, FDA conducted a review of your website, www.alternativecancer.us, and has determined that the marketing of the Test Kits are in violation of the Federal Food, Drug, and Cosmetic Act (the Act). 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 any function of the body.
The violations include, but are not limited to, the following:
Our inspection revealed that the Test Kits 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. § 360(e), 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 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, in that a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k) and 21 CFR 807.81(a)(3)(i). The device is also misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360; and was not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j); or a notice or other information respecting the device was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
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.
We received a response in an email from you dated February 18, 2014 with regards to our latest inspection and deem it inadequate. You do not have an approved PMA/IDE or 510(k).
The above violations are not meant to be an all-inclusive list of deficiencies for your devices and their labeling. It is your firm’s responsibility to ensure that all of your devices and labeling are in compliance with applicable laws and regulations administered by FDA. 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.
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 (which must address systemic problems) 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:
Reference: CMS case # 422768 when replying
If you have any questions about the content of this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at 949-608-2918 or raymond.brullo@fda.hhs.gov.
Alonza E. Cruse, Director
Page Last Updated: 03/10/2015