August 18, 2014
Elhai Grosman, Owner
Elite Massagers, LLC.
101 N. Greenville Avenue, Suite C430
Allen, TX 75002
Dear Mr. Grosman:
During an inspection of your firm located at 610 E. Main Street, Suite 538, Allen, TX 75002 on March 27, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is an initial importer of the Mono Elite Massager and Multi Elite Massager. 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 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. These violations include, but are not limited to, the following:
1. Failure to establish procedures for acceptance activities as required by 21 CFR 820.80(a).
Specifically, your firm receives your Elite Massagers from your contract manufacturer and your firm does not have any procedures that identify your receiving specifications or how your firm will verify the products meet specifications.
2. Failure to establish procedures for corrective and preventive actions as required by 21 CFR 820.100(a).
Specifically, your firm does not have any procedures for corrective and preventive actions.
3. Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198.
Specifically, your firm does not have any procedures for complaint handling.
4. Failure to establish procedures to ensure that all purchased or otherwise received products and services conform to specified requirements as required by 21 CFR 820.50.
For example, you are an initial importer for the Elite Massagers, which you have contract manufactured. You do not have any procedures to control the evaluation of suppliers, define the type and extent of control to be exercised, or to maintain records of acceptable suppliers.
5. Failure to establish procedures for quality audits as required by 21 CFR 820.22.
Specifically, your firm does not have procedures for conducting quality audits.
6. Failure to establish procedures for management reviews required by 21 CFR 820.20(c).
Specifically, your firm does not have procedures for conducting management reviews.
We received your responses dated April 30, 2014 and June 17, 2014 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), Inspectional Observations, that was issued to your firm. Our review of your responses found the response was inadequate. Although you indicate you will correct the deviations through the generation of new procedures, you did not provide copies of the procedures or sufficient detail of the content of the procedures for our review.
MEDICAL DEVICE REPORTING
Our inspection also revealed that your firm’s Elite Massager 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. Significant violations include, but are not limited to, the following:
Failure of your firm to adequately develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
Specifically, your firm does not have any written MDR procedures.
We received your responses dated April 30, 2014 and June 17, 2014 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), Inspectional Observations, that was issued to your firm. Our review of your response found the responses was inadequate. Although you indicate you will correct the deviations through the generation of new procedures, you did not provide copies of the procedures or sufficient detail of the content of the procedures for our review.
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2014.
Therefore all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(o)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
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 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 award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations 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.
In addition, we would like to remind you it is your responsibility to ensure products marketed by your firm have appropriate marketing clearance or approval for all marketed intended uses for your medical devices. We recommend you review the marketing material and labeling for all the medical devices marketed by your firm.
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.
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.
Reynaldo R. Rodriguez, Jr.