Inspections, Compliance, Enforcement, and Criminal Investigations
Home Care Technologies USA, Inc. 2/9/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
February 9, 2012
Mr. Qi (Philip) Zhu, Office Manager
Home Care Technologies USA, Inc.
560 W Main St C827
Alhambra, California 91801-3374
Dear Mr. Zhu:
During an inspection of your firm located in Alhambra, California, on August 15, 2011, through August 18, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm imports and relabels a powered muscle stimulator device. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
Quality System Violations
This inspection revealed that this device is adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 35l(h)), in that the methods used in, or the facilities or controls used for, its 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 and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
For example, your firm does not have any purchasing controls procedures to ensure that all purchased or otherwise received powered muscle stimulator devices conform to specified requirements. Your firm has not evaluated your supplier and vendor of the powered muscle stimulator device, your label manufacturer, or your overseas import broker on their ability to meet specified requirements, including quality requirements.
2. 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, your firm does not have any complaint handling procedures for the powered muscle stimulator device.
3. Failure to maintain Device Master Records (DMRs), as required by 21 CFR 820.181.
For example, your firm does not maintain a DMR for the powered muscle stimulator device.
Specifically, your firm does not have a compilation of records containing or referring to the location of the information regarding the device specifications, production process specifications, quality assurance procedures and specifications, packaging and labeling specifications, and installation, maintenance, and servicing procedures and methods.
4. Failure to establish and maintain procedures to ensure that Device History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of 21 CFR Part 820, as required by 21 CFR 820.184.
For example, your firm does not have any DHR procedures for the powered muscle stimulator device. Your firm does not have device history records documenting the relabeling of your devices, the quantity that were relabeled, and examples of the label and labeling used.
5. Failure to establish and maintain procedures to control labeling activities, as required by 21 CFR 820.120.
For example, your firm does not have any labeling control procedures for the powered muscle stimulator device.
Our inspection also revealed that your firm's device is 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 (MDR). Significant violations include, but are not limited to, the following:
- Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
For example, your firm does not have any MDR reporting procedures.
Unapproved Device Violations
Our inspection also revealed that your firm's device is 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 (IDE) under Section 520(g) of the Act, 21 U.S.C. 360j(g). Your firm's device is 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, 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)] 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/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Your firm's device is not covered by K023001 because your firm's device label, "Got Pain?" brochure, and user manual for the device include claims for the device that were not cleared under K023001 and that represent a major change or modification in the intended use of the device under 21 CFR 807.81(a)(3)(ii). Examples of such claims include, but are not limited to, the following:
(a) The powered muscle stimulator was cleared under K023001 with the following indications:
• Relaxation of muscle spasms;
• Prevention or retardation of disuse atrophy;
• Muscle re-education;
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
• Maintaining or increasing range of motion.
However, your firm's repackaged outer device label, "Got Pain?'' brochure, and user manual contain statements indicating that the powered muscle stimulators are indicated for sports injuries, fibromyalgia, tension and stress, sinus congestion, stiff neck, lower back pain, pinched nerves, bursitis, multiple sclerosis, osteoarthritis, phantom limb) rheumatoid arthritis, diabetic neuropathy, cluster headaches, dental disorders, migraine headaches, sprains/strains, general headaches, Temporomandibular Joint syndrome, ankle pain, foot pain, fractures, knee pain, tendonitis, frozen shoulder, trigger fingers, carpal tunnel, tennis/golf elbow, wrist pain, degenerative disc disease, bulging disc, herniations, sciatic pain, obesity, exercise slimming, insomnia, menstruation pain and irregular menstruation, paraplegia, and massage. These claims fall outside of the scope of K023001 and constitute major changes in the intended use of the device.
(b) The device, as cleared under K023001, is a powered muscle stimulator not a Transcutaneous Electrical Nerve Stimulator (TENS).
However, the outer label, brochure, and user's manual for your firm's powered muscle stimulator contain statements such as "Professional Quality EMS/TENS Home Therapy Massage Unit" and "EMS & TENS frequencies." These claims fall outside of the scope of K023001 and constitute major changes in the intended use of the device.
(c) Your firm's user's manual contains recommendations for placement of the powered muscle stimulator device on the chest, face, and other suggested placements which correspond to transthoracic use, transcerebral use, use in proximity to the carotid sinus nerves, and use in proximity to the neck or mouth.
These claims fall outside of the scope of K023001 and constitute major changes in the intended use of the device.
(d) The powered muscle stimulator was cleared under K023001 for use under the following clinical setting: "The device should only be used under medical supervision for adjunctive therapy for the treatment medical diseases and conditions.'' The powered muscle stimulator is for prescription use only.
However, your firm's repackaged outer label, brochure, and user's manual for the powered muscle stimulator do not include the statement, "Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of the device," as required to identify the devices as prescription use only in accordance with 21 CFR 801.109. A change from prescription use only to over-the-counter use constitutes a major change in the intended use of the device.
Additionally, 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 2011, in that your firm is not properly registered as a repackager/relabeler and has not submitted device listing information.
Therefore your firm's device is misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(o)), in that the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and was 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.
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.
Your firm's response should be sent to:
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions about the contents of this letter, please contact: Dr. Raymond W. Brullo, Compliance Officer at 949-608-2918.
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, Form 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.
Alonza E. Cruse, Director
Los Angeles District