Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
June 14, 2012
Mr. Dvir Le Vran
5247 International Drive, Suite B
Orlando, Florida 32819
Dear Mr. Le Vran:
During an inspection of your firm located in Orlando, Florida, on February 23, through February 24, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures therapeutic massagers. 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 any function of the body.
This inspection revealed that your firm is marketing the Mini, iPRO, Beetle, Nano, Mirco, Medi Pro, and MP5 as massagers. However, based on information obtained during this inspection and the description of these devices, they do not appear to be massagers, but rather powered muscle stimulators and electronic acupuncture devices. 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. § 360e(a), or an approved application for an investigational device exemption under Section 520(g) of the Act, 21 U.S.C. § 360j(g).
The devices 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 these 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) 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 the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
This inspection also revealed that these devices are 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 CFR Part 803 - Medical Device Reporting.
We received a response from your firm dated March 8, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
We reviewed your firm’s response and conclude that it is not adequate. The response indicated that complaint handling procedures were reviewed and updated to reference MDR regulations. However, the response did not address the development of written MDR procedures. Additionally, your firm did not provide evidence to support the implementation of MDR procedures or to show how complaints will be evaluated to determine reportability.
Your firm should take prompt action to correct the violations 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/or civil money penalties. Also, 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 awarding of contracts.
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, as well as 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 actions (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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
In addition, FDA has noted nonconformances with regards to Section 501(h) of the Act, 21 U.S.C. § 351(h), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformances include, but are not limited to, the following:
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: when the investigator asked to review your firm’s complaint handling procedures, your firm’s management stated that the company does not have complaint handling procedures.
We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that it has reviewed and revised its complaint handling procedure to include references to 21 CFR 803 – Medical Device Reporting (MDR). However, it is unclear if adequate written complaint handling procedures have been implemented, as your firm’s management was unable to provide them to the investigator upon request. Your firm also stated that it has retained external consultants to assist in the understanding and application of federal laws and regulations. Additionally, the response indicates that your firm would identify and train persons to ensure timely compliance with the revised procedures. Furthermore, the response states that a review of previous product complaints received was initiated in accordance with your firm’s SOPs. The response did not, however, discuss the depth of review regarding previous complaints, the plan to communicate the review findings to the manufacturer, how outstanding complaint issues will be resolved and future complaints will be handled, or a timeframe within which your firm intends to implement its proposed corrective actions.
Your firm’s response should be sent to: Florida District Office, 555 Winderley Place, Suite 200, Maitland, FL. Refer to the Unique Identification Number 292797 when replying. If you have any questions about the contents of this letter, please contact: Mr. Salvatore N. Randazzo at 407-475-4712 or via fax at 407-475-4769.
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 Inspectional Observations, 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.
Emma R. Singleton
Director, Florida District