| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
FEB 17 2010
WARNING LETTER
VIA FEDERAL EXPRESS
Mr. Craig J. Miles
Managing Partner/Co-owner
White Egret, Inc.
1992 West 3300 South
Ogden, Utah 84401-9774
Dear Mr. Miles:
During an inspection of your firm located in Ogden, Utah on October 27, 2009 through November 4, 2009, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures ear candles. 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. Based on a review of the booklet "Ear Candling" by Anne Tatum, offered on your website www.whiteegrctearcandlcs.com. your ear candles are intended to relieve ear ache, hearing difficulties, tinnitus, labyrinthitis, ear pain, remove earwax, and dry out fluids.
Our inspection and a review of our records revealed your devices arc 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 devices are also misbranded under section 502(o) the Act, 21 U.S.C. 352(0), 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). 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 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your devices 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 your establishment registration for White Egrel, Inc. is not current and there is no device listing for White Egret ear candles. Consequently, your devices are misbranded under section 502(o) of the Act. 21 U.S.C. 352(o), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. 360, and were not included in a list required by section 510(j) of the Act, 21 U.S.C. 360(j).
Your devices are also misbranded under sections 502(a), 502(f)(1), and 502(j) of the Act, 21 U.S.C. 352(a), 352(f)(1), and 352(j), respectively. Specifically, your devices are misbranded under section 502(a) or the Act, 21 U.S.C. 352(a), because the labeling, including the "Ear Candling" booklet, represents the car candles as safe and effective for their intended uses, including the relief of various disorders as described above. For example, the "Ear Candling" booklet states on page 23 that ear candling "treatment is safe, painless and very effective." Your devices are misbranded under section 502(f)(1) of the Act, 21 U.S.C. 352(f)(1), because the labeling fails to bear adequate directions to assure the safe use of the ear candles for the purposes for which they are intended. Your devices are misbranded under section 502(j) of the Act, 21 U.S.C. 352(j), because the devices are dangerous to health when used in the manner or with the frequency or duration prescribed, recommended, or suggested in the labeling. A review of our records reveals that FDA has received medical device reports consistent with the danger to health posed by your devices when used in the manner or with the frequency or duration prescribed, recommended, or suggested in the labeling, including reports involving ruptured tympanic membranes and burns as a result of the use of ear candles. Further, 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, and the "Ear Candling" booklet offered on your website suggests on page 24 that ear candling can be used on children as young as three months old.
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 to comply with the requirements under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Specifically, you have failed to establish written procedures for MDR as required by 21 C.F.R. 803.17. During a review of your firm's Corrective and Preventive Actions (CAPA) subsystem, it was revealed that you have not developed or implemented procedures for handling MDRs.
Additionally, 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 of the Quality System (QS) regulation found at 21 C.F.R. 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 C.F.R.820.30(a). For example, no quality system exists for the design, manufacture, packaging, labeling and storage of White Egret ear candles.
2. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 C.F.R. 820.75(a). For example, the firm's ear candle cutting process, which utilizes a semi-automated cutting machine, has not been validated. Metal mandrels used in production were observed with scouring marks, possibly due to razor blade misalignment during the cutting process. Additionally, razor blades in the machine cutting fixtures were observed to be missing material. There are no procedures or instructions requiring, or records documenting, examination of the ear candles for metal particles after the cutting process.
3. Failure to establish and maintain procedures for receiving, reviewing and evaluating complaints by a formally designated unit, as required by 21 C.F.R. 820.198(a). For example, no quality system exists for the design, manufacture, packaging, labeling and storage of White Egret car candles. In addition, the firm does not maintain complaint records nor does it have procedures covering the handling of complaints.
4. Failure to establish and maintain procedures to ensure that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 C.F.R. Part 803, Medical Device Reporting, as required by 21 C.F.R. 820.198(a)(3). For example, no procedure has been established to ensure that all ear candle complaints are evaluated to determine whether the complaint represents an event requiring the submission of a Medical Device Report.
5. Failure of management with executive responsibility to establish its policy and objectives for, and commitment to, quality and to ensure that the quality policy is understood, implemented, and maintained at all levels of the organization, as required by 21 C.F.R. 820.20(a). For example, no quality system exists for the design, manufacture, packaging, labeling and storage of White Egret ear candles.
6. Failure to maintain device master records (DMR's) and ensure that each DMR is prepared and approved in accordance with 21 C.F.R. 820.40, as required by 21 C.F.R. 820.181. For example, no quality system exists for the design, manufacture, packaging, labeling and storage of White Egret ear candles, and the firm does not maintain DMR's for the ear candles.
7. Failure to maintain device history records (DHR's) and establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR, as required by 21 C.F.R. 820.184. For example, no quality system exists for the design, manufacture, packaging, labeling and storage of White Egret ear candles, and the firm docs not maintain DHR's for the ear candles.
8. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, and failure to document training as required by 21 C.F.R. 820.25. For example, written procedures and/or instructions do not exist for any operation performed at White Egret, Inc., and in addition, the firm does not have any records documenting training of their employees.
9. Failure to establish and maintain a quality system that is appropriate for the specific medical device designed or manufactured, that meets the requirements of 21 C.F.R. 820, as required by 21 C.F.R. 820.5. For example, no quality system exists for the design, manufacture, packaging, labeling and storage of White Egret ear candles.
FDA requests that White Egret, Inc. immediately cease marketing, promoting and distributing White Egret ear candles. This includes the removal of White Egret ear candles and references to ear candling from your website www.whiteegretearcandles.com.
We received your undated response to the lnspectional Observations, Form FDA 483 (FDA 483) from the law firm of Emord & Associates, P.C. on or about November 6, 2009. The adequacy of your response to the FDA 483 cannot be determined at this time. In your response, your attorney states that as of November 1, 2009, you have stopped selling all products labeled as car candles and that you will permanently discontinue the manufacture, distribution, and sale of ear candles and of all products associated with, or concerning, use of candles for affecting the body's structure or function. Your response will be verified during the next scheduled inspection.
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 initialed 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 arc 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 any updates regarding the corrections specified in your response to the FDA 483), 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: Ronald L. Swann at the Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room 3534, Silver Spring, Maryland 20993, facsimile at 301-847-8137. We remind you that only written communications are considered official. If you have any questions about the content of this letter, please contact Ronald L. Swann at 301-796-5770.
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 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/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health
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