Department of Health and Human Services
Public Health Service
Denver District Office
April 11, 2008
VIA CERTIFIED MAIL
Mr. Gene E. Koonce
VIBE Technologies, LLC
2329 W. l0th Street
Greeley, Colorado 80634-3527
Ref.# – DEN-08-12
Dear Mr. Koonce:
During an inspection of your firm located in Greeley, Colorado, on November 5 through November 16, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the V.I.B.E., Vibrational Integrated Bio-photonic Energizer (VIBE) Machine. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), this product is a device 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 is intended to affect the structure or function of the body. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
This inspection revealed that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law. Specifically, the VIBE Machine 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. 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) of the Act, 21 U.S.C. 352(o), in that the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510, 21 U.S.C. 360; was not included in a list required by section 510(j), 21 U.S.C. 360(j); or a notice or other information respecting the device was not provided to the FDA as required by section 510(k), 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 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.
We received written responses from you dated December 3, 2007 and March 18, 2008. In addition, you telephoned our office on April 2, 2008 to provide an update on your activities. We address your responses below.
This inspection also revealed that the device is 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. In your December 3, 2007 letter, you stated that your firm will provide FDA with your plan of corrective actions by January 15, 2008. However, we do not consider your responses to be adequate because, although discussed in the February 20, 2008 meeting held with Denver District office, no documented evidence of corrective actions or time commitments relating to those corrective actions, have been received. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control the design in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).
For example, your firm has not established and maintained a design and development plan (for the VIBE Machine) or procedures for design input, design output, design review, design verification, design validation, design transfer, design changes, and design history files.
2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
For example, there are no procedures for corrective and preventive actions.
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, there are no procedures for handling, receiving, reviewing and evaluating complaints.
4. Failure to establish and maintain adequate procedures for documented instructions, standard operating procedures (SOP’s), and methods that define and control the manner of production, as required by 21 CFR 820.70(a)(1).
For example, production and process procedures are incomplete in that there are no written procedures for the assembly and manufacture of the gas tube assembly (the head) and coil (mast).
5. Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a).
For example, there are no procedures for routine equipment calibration, inspection and maintenance for the [redacted] used to measure the alpha waves emitted by the V.I.B.E. Machine and the [redacted] used to measure ultra violet and infrared frequencies.
These two pieces of equipment are used to conduct finished product testing of the VIBE Machine before its release for distribution.
6. Failure of management with executive responsibility to establish a quality policy with objectives for, and commitment to, quality, as required by 21 CFR 820.20(a).
For example, there is no quality policy for the company.
7. Failure to establish procedures to ensure that the quality system satisfies the requirements of this part, and the manufacturer’s established quality policy and objectives, as required by 21 CFR 820.20(c).
For example, there are no procedures for conducting management reviews. Reportedly, no management reviews have been conducted.
8. Failure to establish and maintain procedures for quality audits, as required by 21 CFR 820.22.
For example, there are no procedures for conducting quality audits.
Our inspection also revealed that your VIBE Machine is 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 device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. 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. For example, your firm has not developed, maintained, and implemented a written MDR procedure.
In your March 18, 2008 letter to FDA, you informed us of your intentions regarding commercial distribution of the VIBE Machine and certain steps you planned to immediately take. Further, on April 2, 2008, you telephoned our office to discuss what steps you had taken or were planning to take with respect to a 510(k) application, Current Good Manufacturing Practice Requirements, and communications with your customers. A follow-up inspection will be required to assure that corrections are adequate. It was noted in the establishment inspection report that the investigator helped you register your firm during the inspection.
You should take prompt action to correct the violation(s) 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: Food and Drug Administration, Denver District Office, P.O. Box 25087, Denver, CO 80225-0087, Attention: Nancy G. Schmidt, Compliance Officer. If you have any questions about the content of this letter please contact: Ms. Nancy Schmidt at (303) 236-3046.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) 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.
H. Thomas Warwick
Denver District Director
This page was posted on June 2, 2008.