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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Healthway Home Products, Inc 28-Sep-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

New York District

Food & Drug Administration
300 Pearl Street, Suite 100
Buffalo, NY 14202


September 28, 2007

WARNING LETTER NYK 2007-21

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Vincent G. Lobdell
President/Treasurer/CEO
Healthway Home Products, Inc.
4941 N. Jefferson St.
Pulaski, New York 13142-4102

Dear Mr. Lobdell:

During an inspection of your firm located in Pulaski, New York on May 4 through May 11, 2007, an Investigator from the United States Food and Drug Administration (FDA) determined that your firm performs release testing and serves as the initial U.S. distributor for Healthway EMF Filtration Systems Portable Room 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.

This inspection revealed that these 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 for devices, which were promulgated under 21 U.S.C. § 360j(f)(1)(A) and set forth in the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for receiving, reviewing and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm has no written complaint handling procedures.

2. Failure to establish and maintain procedures for implementing corrective and preventive action as required by 21 CFR 820.100(a). For example, written quality system corrective and preventive action procedures have not been established to ensure Air Cleaner servicing data is adequately reviewed to identify existing or potential causes of nonconforming product, and to ensure all quality data sources (e.g. quality audits, complaints, acceptance results) are analyzed to identify existing and potential causes of nonconforming product or other quality problems.

3. Failure to establish and maintain procedures for acceptance activities, including inspections, tests, and other verification activities, as required by 21 CFR820.80(a). For example, verification testing, including particulate counts,energy levels, and observations of cosmetic defects, are performed on Air Cleaner units prior to distribution, but your firm failed to establish written procedures that describe the process for performing these verification tests.

4. Failure to document acceptance activities, as required by 21 CFR 820.80(e). For example, there was no documentation of particulate counts, energy levels, and observations of cosmetic defects for the testing/inspection performed as part of finished device testing on Air Cleaners prior to distribution.

5. Failure to define, document, and implement servicing procedures, as required by 21 CFR 820.200(a). For example, procedures for handling Air Cleaner service related issues, including Returned Goods Authorization products, have not been written for performing and verifying that the servicing meet specified requirements.

6. Failure to document applicable tests and/or inspection data for service reports, as required by 21 CFR 820.2{)0(d)(6). For example, customer service report forms fail to include documentation of testing data or verification activities performed to ensure Air Cleaners returned by customers meet specified requirements prior to redistributing the devices.

7. Failure to establish procedures for quality audits, and failure to conduct and document quality audits, as required by 21 CFR 820.22. For example, written quality audit procedures have not been established to ensure quality system audits are conducted. In addition, there is a failure to conduct and document quality audits, including dates and results of the quality audits.

8. Failure to establish and maintain procedures to ensure that inspection, measuring and test equipment is routinely calibrated, inspected, checked and maintained, as required by 21 CFR 820.72(a). For example, written procedures have not been established for acceptance testing equipment (i.e. digital high voltage meter and particle counter) utilized on Air Cleaners prior to distribution to assure the testing equipment are routinely calibrated and properly maintained.

9. Failure to document calibration dates, the individual performing each calibration, and the next calibration date for inspection, measurement and test equipment, as required by 21 CFR 820.72(b)(2). For example, there is no documentation of the calibration dates, the individuals performing the calibration, or the next calibration date, for the high voltage meter utilized during acceptance testing of Air Cleaners.

10. Failure to establish procedures for identifying training needs and ensure that all persons are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, written quality system training procedures have not been established and implemented to ensure employees are adequately trained to their assigned responsibility. In addition, written training procedures have not been established and implemented to ensure proper training is conducted for service technicians/dealers that perform repairs of Air Cleaners in the field.

11. Failure to establish and maintain procedures to control documents required under the Quality Systems regulation, as required by 21 CFR 820.40. For example, written document control procedures have not been established to ensure all quality system forms and procedures are adequately reviewed and approved prior to implementation.

The inspection also revealed that your firm has failed to develop, maintain and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, written procedures have not been developed, maintained, and implemented to ensure adverse events are properly reviewed, evaluated, and reported as required.

A review of agency records reveals that on February 4, 2002, your firm, received a determination of substantial equivalence for a medical air cleaner, permitting you to market it for the intended use of removing particles from the air for medical purposes. (See K 012549). In the course of that review, your firm specifically agreed to numerous changes in your product labeling to remove claims that were not supported by your application, as evidenced by two letters dated January 16, 2002, and one letter dated January 24, 2002. Labeling collected during this inspection indicates that your firm has continued to make claims that were not part of the labeling of the device as FDA cleared it.

Specifically, the product brochure collected during our inspection indicates that you are marketing devices for additional, more specific uses than that for which you received clearance. For example, the product brochure states that among those things that "you can expect from a Health Way air cleaner" are "fewer colds", fewer headaches", and"fewer asthma attacks". These claims represent a major change in intended use that requires submission of a new 510(k) in accordance with 21 CFR 807.81(a). As a result, your firm's Air Cleaners are 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). The device is also misbranded under section 502(o) 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 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) 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). 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.

The inspection also revealed that the sir cleaner devices manufactured by your firm are misbranded within the meaning of Section 502(a), 21 U.S.C. 352(a) in that the labeling for these devices, namely the Healthway Advanced Air Purification Systems box, accompanying product brochure, and owner's manual, contain statements that are false or misleading. The statements indicated below are examples of false or misleading statements found in the device labeling but are not intended to be an all-inclusive list.

For example:
The Healthway Advanced Air Purification Systems box states, "HealthWay's EMF Air cleaner is FDA CERTIFIED." These devices were not certified by the FDA, but were determined to be substantially equivalent within the meaning of section 513(i)(1)(A) of the Act, 21 U.S.C. 360c(i)(1)(A).

Labeling materials also make false or misleading statement regarding your device's ability to kill microorganisms. For example, the box states: "Kills up to 100% of airborne microorganisms." The operator manuals include the following statements: "Destroys 94-100% microorganisms: including viruses, bacteria, mold and fungis pores;" and "Bio Monitor indicator light show continuous microorganism destruction." The product brochure includes numerous similar claims, including "the most revolutionary feature of this system is the constantly maintained high energy field kills airborne viruses, bacteria, mold and fungi spores. EMF technology is proven to kill 94-100% of fungi, 98-100% of bacteria and 100% of dangerous viruses." Likewise, under the heading of "FDA Listed Class II Medical Device," the brochure states "GERM KILLING ZONE! * 99-100% of viruses * 98-100% of bacteria * 94-100% of mold & fungi," creating the additional misleading impression that FDA supports these false or misleading representations. The brochure also quotes from a 2005 report by Kerby Fannin, Ph.B [sic), entitled "Effects of the Health Way Advanced Purification System on the Survival of Microorganisms," making additional similar statements of effectiveness in removing and killing dangerous microorganisms. During the inspection, FDA collected a copy of a report by Mr. Fannin of the same title, dated April 29, 2005, (updating in minor respects a report of August 25, 2000, which had been reviewed by FDA as part of your original 510(k) submission). That report by its own terms indicates that testing was performed to determine "the effect of the Healthway EMF Air Cleaner on the survival of bacteria, molds, and viruses collected on its internal filter" --not any effect on microorganisms while they remain in the air, and not any effect on the total number of microorganisms in the room. In fact, the testing was conducting by directly inoculating filters with test microorganisms and provides no information regarding the ability of the device to kill or destroy any microorganisms that it has pulled from the air. Nor does the collected report make any statements at all about a "high energy field" produced by your device. FDA found the original report submitted in your 510(k) insufficient to substantiate labeling claims for microorganism destruction, and you specifically agreed to remove these claims from labeling prior to FDA's clearance of your device, as demonstrated in your two letters dated January 16, 2002 and letter dated January 24, 2002.

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. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

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, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action 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.

Your response should be sent to FDA Compliance Officer James M. Kewley at the above address. If you have any questions about the content of this letter please contact Mr. Kewley by mail at the above address or by telephone at (716) 541-0328.

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. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Sincerely yours,

/S/

Otto D. Vitillo
District Director
New York District