Inspections, Compliance, Enforcement, and Criminal Investigations
Neurotone Systems, Inc 10-Apr-06
Department of Health and Human Services
Public Health Service
April 10, 2006
RETURNED RECEIPT REQUESTED
Mr. James R. Gilmer
President and Owner
Neurotone Systems, Inc.
510 Nesbit Drive
Garland, TX 75041
Dear Mr. Gilmer:
We are writing to you regarding serious .regulatory problems involving the RelaxPak, Neurotone III, and the Neurotone III D Cranial Electrotherapy Stimulator (CES). 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.
An inspection of your establishment located at the above-referenced address conducted on September 19, 2005 through October 7, 2005, by investigators from the Food and Drug Administration (FDA) revealed violations of the Act regarding these devices. At the conclusion of the inspection, a Form FDA-483, List of Inspectional Observations, was issued to you.
The inspection revealed that the devices listed above are adulterated under section 501(h) of the Act, 21 U.S.C. § 351(h), because the methods used in, or the facilities or controls used for, their manufacture, processing, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for devices, which are set forth in the Quality System (QS) Regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations 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 [FDA-483 Item 3]. Your firm has made design changes to the above-referenced devices without establishing procedures to document, approve, validate or verify design changes before their implementation, as required by 21 CFR 820.30(i). In 2003, your firm designed, manufactured, and introduced the Neurotone III D into the market without establishing adequate design control procedures.
2. Failure to establish, and maintain procedures for monitoring and control of parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75. [FDA-483 Item 4). Where the process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, must be documented. For example, your firm has not validated the software used in the Neurotone III D CES device. The Neurotone III D CES device has a microprocessor programmed with specific -software to control the [redacted] and alternate the [redacted] Procedures for validating the device design to ensure that the device conforms to defined user needs and intended uses have not been provided, nor has the software validation been performed.
3. Failure to establish and maintain process control procedures, including documented instructions, standard operating procedures (SOPs), and methods, that define and control the manner of production, as required by 21 CFR 820.70(a)(1) [FDA-483 Item 7]. For example, your firm does not have written assembly procedures for the manufacture of the Neurotone III and Neurotone III D CES devices.
4. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d), and failure to maintain acceptance records, as required by 21 CFR 820.80(e) [FDA-483 Item 81. For example, although your firm verbally stated that it manufactured and tested each CES device, you could not provide any records of the test results for the final product testing.
5. Failure to establish and maintain procedures for acceptance of incoming product, including documentation of acceptance or rejection, as required by 21 CFR 820.80(b) [FDA-483 Items 7 and 8]. For example, your firm could not provide or has no written procedures for, or documentation of, inspection, testing, or verification of incoming products (e.g., electrodes, printed circuit boards, and other incoming components).
6. Failure to establish and maintain procedures to control product that does not conform to specified requirements, including the identification, documentation, evaluation, and disposition of nonconfomzing product, as required by 21 CFR 820.90(a) [FDA-483 Item 9]. For example, you verbally confirmed that in a number of instances your firm rejected and returned defective printed circuit boards (PCB) to the PCB manufacturer for rework. Your firm has not established procedures addressing how the devices or the printed circuit boards are to be reworked and retested for acceptance and where the results of the rework are to be documented.
7. Failure to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184 [FDA-483 Item 12]. For example, your firm has not maintained any device history records for the CES devices. Additionally, your firm has not established procedures defining the specific types of information (e.g., acceptance results, dates of manufacturing, quantity manufactured and released for distribution, device labels and labeling) to be included in the device history records.
8. Failure to maintain device master records (DMRs) to include or refer to the location of, device specifications, production process specifications, quality assurance procedures, and packaging and labeling specifications, and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181 [FDA-483 Item 5]. A complete device master record for each of the three CES models (RelaxPak, Neurotone III, and Neurotone III D) was not maintained. For example, your firm failed to (a) approve and document product history of changes (a description of changes to the devices, changes to device's component specifications, etc.) from RelaxPak to Neurotone III and from Neurotone III to Neurotone III D; (b) maintain complete device labels and labeling; and (c) establish quality assurance testing procedures (final product testing).
9. Failure to establish and maintain adequate complaint handling procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to ensure that all the requirements of 21 CFR 820.198 are met (FDA-483 Item 11]. For example, your firm verbally confirmed that in a number of instances, you received complaints of defective components or malfunctioning devices, but that you did not maintain records of these complaints. Furthermore, your firm has not established any complaint handling procedures.
10. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803 and to promptly review, evaluate, and investigate such complaints, and maintain them in a separate portion of the complaint files or otherwise clearly identify them, as required by 21 CFR 820.198 [FDA-483 Item 13]. For example:
a. Your firm does not have a standardized review process and procedures to determine whether incoming complaints meet the criteria for an MDR reportable death, serious injury, or malfunction.
b. Your firm does not require that MDR reportable events are promptly reviewed, evaluated, investigated, and reported to FDA and that records of investigation contain the information required under 21 CR 820.198(d).
At the conclusion of our inspection, you verbally confirmed that your firm did not have written MDR procedures. In your October 14, 2005, letter you stated that you were able to locate a MDR procedure, but recognized that this MDR procedure was outdated (approved on October 18, 1985). Our review of the dated MDR procedure revealed that your firm failed to revise this procedure to reflect the requirements of the revised MDR regulation that became effective on July 31, 1996.
In addition, the Neurotone III D device is adulterated and misbranded because your firm failed to submit a 510(k) premarket notification for new indications for use and modifications to the device that could significantly affect the safety and effectiveness of the device, as required by Section 510(k) of the Act and Title 21, Code of Federal Regulations (CFR), Part 807.81. In contrast to the predicate device, the Neurotone III D device has two electrical outputs, is software controlled, and the [redacted]. In addition, the device is intended for treatment of insomnia, depression, anxiety, improving sleep, and reducing fatigue. Consequently, the device 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), 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).
Responding to This Letter
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and the regulations. The specific violations noted in this letter and in the Form FDA- 483 may be symptomatic of other serious underlying problems in your firm's manufacturing and quality assurance systems.
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, no applications for premarket approval to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these violations. Failure to promptly correct these violations 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 penalties.
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken, or will take to identify and correct the noted violations, including (1) the timeframes within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to ensure that similar violations will not recur.
Your response should be sent to Thao Ta, Compliance Officer, DAL-DO, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, TX 75240. If you have any questions about the contents of this letter, please contact Mr. Ta at 214-253-5217.
Michael A. Chappell
Dallas District Director