Department of Health and Human Services
|Public Health Service
Food and Drug Administration
555 Winderley PI., Ste. 200
Maitland, FL 32751
RETURN RECEIPT REQUESTED
August 31, 2009
Robert A. Besner
Chief Executive Officer
21000 Boca Rio Rd Ste A21c
Boca Raton, FL 33422-1551
Dear Mr. Besner:
During an inspection of your firm located in Boca Raton, Florida on January 12-13, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the following products: Therasage RX Healing Pads (Small, Small with Car Adapter, Medium, and Large), Therasage RX Healing Belt, the Therasage Rx Massage Beds (Models: 8000S and 8001), and TheraDesign Clothing, Bandages, and Wraps (Models: Wrist Band, Calf Band, Elbow Band, Knee Band, Ankle Band, Therapy Socks, Shoulder Cover, Therapy T-shirt, and Waist Belt). 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.
We received your response dated March 14, 2009, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to you on January 13, 2009. We address this response below in relation to each of the noted violations.
Our inspection revealed that the Therasage RX Healing Pads, Therasage RX Healing Belt, Therasage Rx Massage Beds, and TheraDesign Clothing, Bandages, and Wraps identified above and the Therasage Home Saunas (2, 3, and 4 Person) are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C.. § 351(f)(1)(B), because you do not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C.. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C.. § 360j(g). The devices are also misbranded under section 502(0) the Act, 21 U.S.C.. § 352(0), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C.360(k). For a device requiring market 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 C.F.R. § 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/dcvadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
In your letter dated March 14, 2009, you claim that since your firm does not manufacture the devices, but instead is an initial importer/distributor, you are not required to submit premarket notification submissions (510(k)s) for these devices. We have reviewed your response and have concluded that it is not adequate. You engage in manufacturing activities, which includes relabeling initial importation of devices manufactured in foreign establishments, and initiating specifications. See 21 C.F.R. § 807.3(d). For example, you state that Therasage developed the User Guide and Instruction Manual & Warranty Information included with the Healing RX Pads. You explain that Therasage developed the warning statements included in the labeling for the Healing RX Pads. Moreover, you indicate that Therasage provided input to the labeling for the Healing RX Belts. Further, Therasage directed the addition of a warning on not using the Healing RX Belt when the product is charging. With respect to TheraDesign, your website indicates that TheraDesign is a co-venture of Therasage and that the "new healing fabrics" that are used in the bandages, wraps, and clothing "have been developed by TheraDesign." It also states that "TheraDesign developed various types of wraps which are designed for use on those parts of the body which may suffer from aches, sprains, or other soft tissue injuries."
Regardless of your status as a manufacturer, the Act requires that "each person who is required to register. ..and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution" of a device submit a premarket notification (510(k)). 21 U.S.C. § 360(k). The regulations reiterate this requirement and state that any person "who is required to register his establishment pursuant to § 807.20 must submit a premarket notification." 21 C.F.R. § 807.81. Accordingly, your firm constitutes an entity that is required to register, has in fact registered, and must submit a 510(k) in order to distribute these devices in interstate commerce. A review of our records indicate that no 510(k) has been cleared for the Therasage RX Healing Pads, Therasage RX Healing Belt, the Therasage Rx Massage Beds, and TheraDesign Clothing, Bandages, and Wraps identified above and the Therasage Home Saunas. Introduction or delivery for introduction into interstate commerce of an adulterated or misbranded device is prohibited under section 301(a) of the Act. 21 U.S.C.. § 331 (a). Because, as described above, your devices are adulterated and misbranded, your continued introduction of these devices into interstate commerce without a PMA or 510k) is a prohibited act.
You also state in your letter that the foreign manufacturer of the Therasage Healing Pad will submit a § 513(g) Request for Classification by March 20, 2009, to determine the proper classification of the device for any subsequent regulatory filing. A review of our records show that no § 513(g) Requests for Classification have been submitted either by you or any other party, nor are there any cleared or pending 510(k)s for any of the devices listed above.
Our inspection also revealed that the Therasage RX Healing Pads, Therasage RX Healing Belt, and the TheraDesign Clothing, Bandages, and Wraps are also misbranded under section 502(0) of the Act, 21 U.S.C. § 352(0), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510, 21 U.S.C. § 360, and were not included in a list required by Section 510(j), 21 U.S.C. § 360(j). Specifically, a review of our records reveals that your firm has not submitted a device listing for these devices.
Our inspection also revealed that your firm's 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 devices that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to the following:
1. Failure to furnish written MDR procedures, as required by 21 C.F.R. § 803.17.
Your firm has not established an MDR procedure that addresses these regulatory requirements. For example:a. There are no internal systems that provide for:
i. Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;
ii. A standardized review process or procedure for determining when an event meets the criteria for reporting under the MDR regulations; and
iii. Timely transmission of complete medical device reports to FDA.b. There are no documentation and recordkeeping requirements for:i. Information that was evaluated to determine if an event is reportable;
ii. All medical device reports and information submitted to FDA; and
iii. Systems that ensure access to information that facilitates timely follow up and inspection by FDA.
We have reviewed your response and have concluded that it is inadequate. You have not yet submitted an established and implemented MDR procedure for our review. You state that as an initial importer, your responsibility is only to report a possible MDR to the manufacturer in a timely manner, however, as described above, your firm engages in manufacturing activities. Under 21 C.F.R. § 803.3, a manufacturer includes repackagers or relabelers, specification developers, and U.S. agents of foreign manufacturers. Since you meet the definition of a manufacturer, you are required to fulfill the MDR responsibilities enumerated for a manufacturer under 21 C.F.R. Part 803.
This inspection also revealed that your 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to, the following:
- 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 C.F.R. § 820.30(a). For example, your firm has not established design control procedures.
- Failure to establish and maintain a design history file for each type of device that contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan. For example, your firm has not established design history files.
- Failure to establish and maintain procedures for implementing corrective and preventive actions (CAPA), as required by 21 C.F.R. § 820. 100(a). For example, your firm has not established CAPA procedures.
- 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 C.F.R. § 820.50. For example, your firm has not established purchasing control procedures.
- Failure to maintain a record of a complaint investigation as described in 21 C.F.R. § 820.18(e). For example, your firm failed to document the nature and details of complaints, the results of investigation, and any corrective action.
- Failure to establish procedures for quality audits and to conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 C.F.R. § 820.22. For example, your firm has not established and implemented an internal audit procedure. In addition, your firm has failed to conduct internal audits.
We have reviewed your response and have concluded it is inadequate because you have failed to implement the necessary corrective actions and provide documentation to demonstrate that you have established and implemented the corrective actions you listed in your response.
You 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, 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.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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.
Your response should be sent to: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact: Mr. Alejo at (407) 475-4731.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of these violations, and take prompt actions to correct the violations and to bring your products into compliance.
Emma R. Singleton
Director, Florida District
This page was posted on January 31, 2010.