Inspections, Compliance, Enforcement, and Criminal Investigations
Tonica Elektronik A/S 11/6/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
NOV 6, 2012
November 6, 2012
VIA UNITED PARCEL SERVICE
Owner and Chief Executive Officer (CEO)
Tonica Elektronik, A/S
Dear Mr. Anderson:
During an inspection of your firm located in Farum, Denmark,on July 30, 2012, through August 2, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Magnetic Stimulators. 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 to affect the structure or function of the body.
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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. FDA received a response from you dated August 20, 2012, concerning the investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address the responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to adequately ensure, when the results of a process cannot be fully verified by subsequent inspection and test, that the process is validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example, your firm’s manufacturing process for Cool B65 coils includes (b)(4). The investigator noted that the final inspection of the product would not determine the strength of the coil. The Cool B65 coil manufacturing flow diagram does not indicate that process validation occurs for this (b)(4). In addition, the process conditions ((b)(4)) are not documented.
The adequacy of your response dated August 20, 2012, cannot be determined at this time. Your firm provided documentation indicating that new production processes have been developed, conducted, controlled, and monitored for the Cool B65 coil. However, no documentation was provided indicating that process validation has been established in the Cool B65 coil (b)(4). Your firm also did not provide documentation or evidence of consideration of a systemic corrective action to ensure that process validation has been established in all production processes where the results of the process cannot be fully verified by subsequent inspection and test.
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 history file indicated that the design validation was not documented for design changes made to the Cool B65 coil.
The adequacy of your response dated August 20, 2012, cannot be determined at this time. Your firm provided documentation indicating the design validation for design changes. However, your firm did not provide documentation or evidence of consideration of a systemic corrective action to include review of all device design changes to ensure that documented validations for intended uses were conducted as required.
3. Failure to establish and maintain procedures for verifying the device design to confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f). For example, the design verification for the Cool B70 coil determined that the handle temperature was (b)(4)°C. According to the test procedure requirement, the “Cable and handle surface must never exceed (b)(4)°C.” Additionally, the design verification for magnetic field plot for the Cool B70 coil did not demonstrate that acceptance criteria were met. The acceptance criteria state that the Cool B70 coil would have a magnetic field measurement within (b)(4)% of the reference coil at the specified distances. The results only showed graphs for the two coil types. The graphs did not show that the field outputs are within the required (b)(4)% at the specified distances.
The adequacy of your response dated August 20, 2012, cannot be determined at this time. Your firm provided an updated design verification test report for the Cool B70 coil. Your firm added a rationale for accepting handle temperatures outside of test procedure requirements. Your firm also included magnetic field testing and a comparison with the magnetic field measured on the standard Cool B70 coil. However, your firm did not provide documentation that the design validation procedure was revised to include the rationale provided in the verification test report. Your firm also did not provide documentation or evidence of consideration of a systemic corrective action that includes documentation that design verification confirms that design output meets the design input requirements for all devices.
During the course of the inspection, your firm’s catalog, entitled “MagPro coils: Versatility in Magnetic Stimulation,” was collected. This catalog is distributed in the United States. It promotes and advertises four coils with clearance under section 510(k) of the Act, 21 U.S.C. § 360(k) (MCF-75, MCF-125, MCF-B65, and Cool-B65). The MCF-75 model lists “Motor Cortex” as an application and the MCF-125, MCF-B65 and Cool-B65 models list “Brain tissue” as an application. These stimulation targets are different from “peripheral nerves,” which is the cleared indication for use in your 510(k).
Therefore, these devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360(e)(a), or an approved application for an investigational device exemption under section 520(b) of the Act, 21 U.S.C. § 360j(g). They are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution for the new intended use as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
Additionally, the catalog does not specify whether the “Applications” listed are diagnostic or therapeutic. There is a difference between diagnostic and therapeutic intended uses, which may require a new 510(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). The kind of information that your firm needs to submit in order to obtain approval or clearance for its device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html.
The Office of Compliance requests that Tonica Elektronik, A/S, immediately cease making claims that are the same as or similar to claims addressed in this letter. 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 civil money penalties.
A follow-up inspection will be required to assure that corrections and/or corrective actions are adequate.
U.S. Federal Agencies may be advised of the issuance of 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case 341501. If you have any questions about the contents of this letter, please contact: Tanisha Hithe at 301-796-5524.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483 issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and