Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health|
9200 Corporate Blvd
Rockville, MD 20850
VIA FEDERAL EXPRESS
December 10, 2008
Savec Health Systems
120 Deramore Avenue
Re: Omnivir Device
Dear Admare Jinga:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Omnivir device in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) has reviewed your website, www.savechealthsystems.com, for the Omnivir product. The Omnivir is a device within the meaning of Section 201(h) of the Act, 21 U.S.C. 321(h),because it is 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 function of the body.
The Omnivir device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act. 21 U.S.C. 360j(g). The device is also misbranded under section 502(0) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by sections 510(k) of the Act. 21 U.S.C. 360(k).
The Onmivir device is also misbranded under section 502(a) of the Ac, 21 U.S.C. 352(a) in that the labeling for the device, namely your website and the Patient Information Leaflet available on your website, contain statements which represent or suggest that the device is adequate and effective to "'[f]ight HIV/AIDS and related opportunistic infections" and "[protect] the immune system." which representations or suggestions are false or misleading or otherwise contrary to fact because the device is not adequate or effective for such purposes.
The Omnivir device is also misbranded under section 501(j) of the Act U.S.C. 352(j), in that the device is dangerous to health when used in the manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof, FDA has reviewed your labeling, the Patient Information Leaflet available on your website, and has determined that the Omnivir device is dangerous to health when used in the manner, frequency, and duration prescribed, recommended, and suggested therein. Specifically, the Patient Information Leaflet provides instructions to insert the device into patient's rectum and administer the medicine, oxygen/ozone gas mixture, in accordance with the recommended dosage, dosage duration, and dosage level function. These instruction do not adequately describe measure to prevent risk of infection and spread of communicable disease between patients.
Given the serious nature of the violations of the Act, the Omnivir device manufactured by your firm is 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 and misbranded. 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 device from detention, you 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 response is adequate.
The Office of Compliance requests that Savec Health Systems immediately cease the dissemination of all promotional material, included those one the internet for the Omnivir device the same as or similar to those described above. You should take prompt action to correct the violations addressed in this letter.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for the Omnivir device the same as or similar to those described above, and explaining your plans for discontinuing use of such materials. Please direct your response to Amy Skrzypchak at the Food and Drug Administration, 2094 Gaither Road, Rockville, MD 20850, facsimile at 1-(240) 276-0129. We remind you that only written communication are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for the Omnivir device comply with each applicable requirement of the Act and FDA implementing regulations.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and Radiological Health
This page was posted on July 19, 2010.