| Public Health Service Food and Drug Administration |
| San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510/337-6700 |
Department of Health and Human ServicesVIA FEDERAL EXPRESS
February 17, 2010
Ms. Terese A. Sheppard
President
Wally's Natural Products, Inc.
11837 Kemper Road, Suite 5
Auburn, California 95603
Dear Ms. Sheppard:
During an inspection of your firm located in Auburn, California on June 25, 2009 and July 15, 2009, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures ear candles. Based on the labeling for your product, your ear candles are intended to help relieve pain and itching from infections and other conditions, soften old, hardened earwax, assist the body to excrete excess ear wax, and remove fluids from the ear.
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.
Our inspection revealed your devices 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(0) of the Act, 21 U.S.C 352(0), 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, under Title 21, Code of Federal Regulations (CFR) 807.81(b), 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. 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, a review of our records revealed that your establishment registration for Wally's Natural Products is not current and that there is no device listing for Wally's Ear Candles. Consequently, your devices are misbranded under section 502(0) of the Act, 21 U.S.C. 352(0), III that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510, 21 U.S.C. 360, included in a list required by section 510(j), 21 U.S.C. 360(j), and a notice or other information respecting the devices was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k).
Your device is also misbranded under section 502(j) of the Act, 21 U.S.C. 352(j), because the device is dangerous to health when used in the manner or with the frequency or duration prescribed, recommended, or suggested in the label. A review of our records revealed that FDA received six (6) Medical Device Reports involving ruptured tympanic membranes and bums as a result of the use of ear candles. Two (2) of the Medical Device Reports were specific to the use of Wally's Ear Candles.
Our inspection also revealed that your 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 any material or information respecting the device that is required to comply with the requirements under section 519 of the Act and 21 CFR Part 803 - Medical Device Reporting (MDR). Specifically, you have failed to establish written procedures for MDR as required by 21 CFR 803.17. For example, during a review of your firm's corrective and preventive action subsystem it was revealed that you have not developed or implemented procedures for handling MDRs.
Additionally, the 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 of the Quality System (QS) regulation found at 21 CFR Part 820. These violations include, but are not limited to, the following:
1. 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. For example, a review of your firm's Design Controls subsystem revealed that you have not established design controls for your ear candle products including design and development planning, design inputs, design outputs, design review, design verification, design validation, design transfer, and design history files.
2. Failure to establish and maintain procedures for the identification, documentation, validation, or where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, a review of your firm's Design Controls subsystem revealed that there have been no procedures established for the identification, documentation, validation, verification, review, and approval of design changes before implementation. Specifically, your firm changed the design of the ear candles by adding two safety features; (b)(4) These changes to design were not validated or verified.
3. 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, a review of your firm's Corrective and Preventive Action subsystem revealed no written procedure for receiving, reviewing, and evaluating ear candle complaints by a formally designated unit and no procedure is in place to ensure that ear candle complaints are evaluated to determine whether the complaint represents an event requiring the submission of a Medical Device Report, as required by 21 CFR 820.198(a)(3).
4. Failure to establish procedures for quality audits and 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. For example, a review of your firm's Management Controls subsystem revealed that you have not established procedures for conducting internal quality audits of the quality system relating to the manufacture of ear candles.
In addition to the violations listed above, FDA is aware that these devices may be promoted for use in children of any age, including babies, putting them at increased risk for injuries and complications.
FDA requests that Wally's Natural Products immediately cease marketing, promoting and distributing Wally's Ear Candles to soften, loosen, and help break up ear wax. This includes the removal of Wally's Ear Candles and references to ear candling from your website www.wallysnatural.com.
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 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, which may include notification of your current and past customers. Your response should also include 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.
Additionally in your response, please indicate what you plan to do with existing stock and products in the field that have been previously shipped and are still in stock.
Your response should be sent to: Mr. Lawton W. Lum, Compliance Officer. If you have any questions about the content of this letter please contact: Mr. Lum at (510) 337-6792 or by fax at (510) 337-6703.
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, issued at the close of the inspection maybe 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/
Barbara J. Cassens
District Director
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