Inspections, Compliance, Enforcement, and Criminal Investigations
Neuro-Fitness, L.L.C. 30-Jan-06
Department of Health and Human Services
Public Health Service
January 30, 2006
RETURN RECEIPT REQEUSTED
In reply refer to Warning Letter SEA 06-17
Lawrence Paros, President
Neuro-Fitness, L.L.C .
P.O. Box 1031
Fall City, WA 98065
Dear Mr. Paros:
The Food and Drug Administration (FDA) conducted an inspection of your establishment located at 33631 #2 Redmond-Fall City Road, Fall City, Washington, on August 17 and 25, 2005. Our investigator determined that your establishment markets and distributes a device identified as a cranial electrotherapy stimulator, which is a medical device as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(h)). At the conclusion of the inspection, a Form FDA 483, Inspectional Observations was issued to you .
Your firm received a letter of substantial equivalence K895175 dated November 8, 1989, for a cranial electrotherapy stimulator. Our review of information collected during the inspection determined that you made a significant modification to the design of the device by changing the mode of operation to 0.35 Hz. This change could significantly affect the safety or effectiveness of the device. Your device is misbranded under section 502(o) of the Act [21 U.S.C. 353(o)] in that a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k) and 21 CFR §807 .81(a)(3)(i).
Your firm's cranial electrotheraphy stimulator with the .35 Hz mode of operation is adulterated under section 501(f)(1)(B) of the Act [21 U.S .C. 351(f)(1)(B)] in that it is a class III device under section 513(f) and does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) or an approved application for an investigational device exemption under section 520(g).
For a device requiring premarket approval, the notification required by section 510(k) of the Act 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 premarket clearance is available through the Internet at http://www.fda.gov/cdrh/devadvice/3122.html
In addition, our inspection revealed that this 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 manufacturing, packing, storage, or installation are not in conformance with the current Good Manufacturing Practice (cGMP) requirements for medical devices, which are set forth in the Quality System Regulation (QSR), as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
1. Failure to establish quality system procedures and instructions, as required by 21 CFR 820.20(e). To date, you have had your contract manufacturer produce [redacted] CES Ultra Units, which you have received. You have sold approximately [redacted] units to distributors with no quality system procedures.
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). You made a significant modification to the design of your device by changing the mode of operation to 0.35 Hz . You made this change without any documentation, approval, or validation.
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. You have not implemented procedures for evaluation of the contract manufacturer, or for the maintenance of purchasing data that describes or references specified requirements for purchased or received product. In addition, you have not defined the type and extent of control to be exercised over the products and services of your contract manufacturer. For example, you have no documentation of the evaluation of [redacted] your contract manufacturer in [redacted] of the CES Ultra Device.
4. Failure to establish and maintain document control procedures, as required by 21 CFR 820.40. You have not implemented written document control procedures including procedures to cover approval of document and document changes.
5. Failure to establish and maintain a device master record that includes or refers to the location of all quality assurance procedures and specifications including acceptance criteria to be used, as required by 21 CFR 820.181(c). Your finished product testing procedures or specifications are not included in your quality system records. Your records of product testing completed by your contract manufacturer, by an independent testing firm, and by your employees do not describe the testing procedure, acceptance parameter, or inclusion of quality assurance procedures and device specifications as part of the device master record.
6. Failure to document the quality policy and objectives, as required by 21 CFR 820 .20(a). You have no documentation for a quality policy or objectives.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to all applicable FDA regulations and the Act.
You should take prompt action to correct these violations. Failure to correct these violations promptly may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Federal agencies are advised of the issuance of Warning Letters regarding 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 receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent the recurrence of similar violations. 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 reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483- 4913.
Charles M. Breen