Department of Health and Human Services
|Public Health Service
Food and Drug Administration
555 Winderley PI., Ste. 200|
Maitland, FL 32751
RETURN RECEIPT REQUESTED
January 3, 2008
John O. Shannon, President
Care Tech Industries, Inc.
8976 Seminole Boulevard
Seminole, Florida 33772
Dear Mr. Shannon:
During an inspection of your firm located in Seminole, Florida from July 23 through July 25, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Odatus® recirculating air cleaners. 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 are intended to affect the structure or function of the body.
A review of your product labeling for the Odatus® recirculating air cleaners reveals that you are promoting these products for use in "The 'Elimination of ... Ebola, Tuberculosis, Streptococcus, ... Asthma Attacks, Allergies, Infections, Fatigue, Depression, ... Colds, Flu, Viruses, Respiratory, and Eye Infections, ... Lung Damage, ... [and] Brain Damage." The products are therefore intended for use in the cure, mitigation, treatment, or prevention of disease, rendering them devices under section 201(h) of the Act, 21 U.S.C. 321(h). Your firm's website, which markets these products and is located at http://www.odatus.com, http://www.odatus.net, and http://www.odatus.org, also indicates that your device is intended for use in mitigating and preventing disease, including cancer, asthma, lung damage, brain damage, depression, and infections (eye, nose, and sinus).
The FDA has received your July 30, 2007, written response to the inspectional observations issued to you at the close of the inspection. You state in this response that these medical claims will be immediately removed from your finn's website. As of December 19, 2007, however, these medical claims still remain on your website. Moreover, your response fails to address the removal of medical claims from printed product labeling, such as brochures and owner's manuals, for the Odatus® recirculating air cleaners. Because you continue to market your products for use in curing, mitigating, treating, or preventing disease, they are devices under section 201(h) of the Act, 21 U.S.C. 321(h).
510(k) / PMA Deficiencies
The inspection revealed that the Odatus® recirculating air cleaner devices are misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). The devices are also 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. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). 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 agency. 21 CFR 807.81(b).
- On May 9, 2005, your firm submitted a 513(g) request to the FDA, requesting information concerning the status of the Odatus devices and their classification and regulatory requirements.
- By letter dated July 6, 2005, the FDA informed your firm that the Odatus devices were considered to be class II devices. The FDA advised your firm that you must submit a premarket, notification [510(k)] and receive FDA clearance prior to marketing the Odatus air purifiers.
- Your firm submitted a response to the FDA on July 20, 2005, stating that your devices do not "remove particles from the air" and that you disagreed with the FDA's classification of the Odatus® air cleaner as a Class II device.
- The FDA responded to your letter on August 3, 2005, reiterating that the Odatus® air cleaner is a Class II device and that your firm will need 510(k) clearance from FDA prior to marketing the device.
After this correspondence, your firm neither pursued any further correspondence nor filed a 510(k) premarket application with the FDA. In your July 30, 2007, response, you state that "the manufacturing of the Odatus line for purchase has been discontinued effective July 25, 2007." As of December 19, 2007, however, your firm's website still offers a "FACTORY LIQUIDATION SPECIAL" a few lines below, the "PUBLIC NOTICE" section of http://www.odatus.com, http://www.odatus.net, and http://www.odatus.org, indicating your firm's intent to continue to market its unapproved and uncleared devices despite the numerous warnings from the FDA. As of December 19, 2007, your firm continues to market these devices without obtaining marketing approval or clearance, which is a violation of the law.
The FDA is once again reminding your firm that you must obtain marketing approval or clearance for the Odatus® recirculating air cleaner devices. The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Additionally, the Odatus® recirculating air cleaner devices are misbranded under section 502(j) of the Act because they generate ozone in excess of the maximum acceptable concentration set forth in 21 CFR 801.415(c)(1). The FDA has determined that ozone, is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. 21 CFR 801.415(a). The maximum acceptable level for ozone is 0.05 parts per million (ppm) by volume of air and applies to any device, whether portable or permanent or part of any system, which generates ozone by design or as an inadvertent or incidental product. 21 CFR 801.415(c)(1). Your firm's website states that one Odatus generator plate produces cold plasma ozone from 0.05 ppm on the low setting to 0.2 ppm on the high setting -- up to four times the maximum acceptable concentration of ozone. Because your Odatus air purifiers generate ozone in excess of the allowable limit, they are considered misbranded under 502(j) of the Act, for being dangerous to health when used in the manner suggested. 21 CFR 801.415(c).
Facility Registration / Device Listing Deficiencies
The inspection also revealed that the Odatus® recirculating air cleaner devices are misbranded under section 502(o) the Act, 21 U.S.C. 352(o), in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510, 21 U.S.C. 360, and were not included in a list required by section 510(j), 21 U.S.C. 360(j). Specifically, on August 6, 2007, the FDA processed a request signed by you indicating that your firm is no longer a device establishment. The FDA promptly updated your firm's status to reflect that you are no longer manufacturing medical devices. The FDA also removed the Odatus air cleaners from the device listing. Yet your firm continues to market these medical devices and distribute them into interstate commerce, which is a violation of the law.
Quality System Deficiencies
Additionally, the inspection revealed that the Odatus® recirculating air cleaner devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation, Title 21, Code of Federal Regulations, Part 820 (21 CFR Part 820). These violations are as follows:
(1) Failure to establish and maintain procedures for validating the device design, including a risk analysis, as required by 21 CFR 820.30(g). Specifically, your firm failed to perform a risk analysis to demonstrate adequate mitigation of identified risks such as:
(a) the production of hazardous byproducts, such as nitric, oxide, during the generation of refined ozone;
(b) ozone emission levels above allowable limits -(maximum acceptable level of 0.05 ppm ozone by volume when used in houses, apartments, offices, etc., under standard conditions of 25°C and 760 mm of mercury); and
(c) potential harm to individuals who are exposed to the levels of ozone that are generated by your firm's air cleaner.
(2) Failure to establish and maintain procedures for finished device acceptance to assure that each lot of finished device meets acceptance criteria, as required by 21 CFR 820.80(d). Specifically, your firm does not perform or document any finished device performance testing, including verification of accuracy for ozone emissions settings per device specification.
(3) Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your firm does not have any purchasing control to verify the quality of components received from suppliers.
(4) Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints to determine whether the complaint represents an event that is required to be reported to the FDA under 21 CFR Part 803, as per 21 CFR 820.198(a)(3). Specifically, your firm does not have any procedures for the handling of complaints.
(5) Failure to review and evaluate all complaints to determine whether an investigation is necessary, as required by 21, CFR 820.198(b). Specifically, your firm received a complaint on December 5, 2005, from a customer who claimed that the device "does not fully disclose potential health hazards for persons (with lung disease) who use the product..." During the July 2007 inspection, your firm told FDA investigators that the ozone your devices produce is not hazardous. Yet your firm has failed to conduct any investigation into the complaint and has failed to document any follow-up with the complainant to determine whether his/her claim was substantiated.
(6) Failure to establish procedures for quality audits and failure to conduct such audits to, assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. Specifically, your firm does not have any quality audit procedures and does not perform any quality audits.
(7) Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). Specifically, your finn does not have any design control procedures for the Odatus Air cleaner to assure that design inputs, design outputs, design reviews, design validation and/or verification, and design transfer have been successfully performed. Your firm does not have any procedures to address design changes and does not maintain. a design history file for the device.
(8) Failure to establish and maintain procedures for implementing corrective and preventive actions (CAPA), as required by 21 CFR 820.100(a). Specifically, your firm does not have any CAPA procedures.
Your July 30, 2007, response is inadequate in that it does not set fort h any corrective actions that your firm will take to address these deviations from the Quality System regulation.
Medical Device Reporting Deficiencies
The inspection also revealed that the Odatus® recirculating air cleaner 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 devices as required by section 519 of the Act, 21 U.S.C. 360(i), and. 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following: failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. Specifically, your firm does not have any formalized procedures for handling of MDRs.
Your July 30, 2007, response is inadequate in that it neither addresses your firm's lack of MDR - procedures nor discusses your firm's corrective actions to remediate this deviation.
You 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your response to the U.S. Food and Drug Administration, Attention: Matthew B. Thomaston, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issue in this letter, please contact Mr. Thomaston at (407) 475-4728.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA.
Emma R. Singleton
Director, Florida District
This page was posted on July 19, 2010.