Inspections, Compliance, Enforcement, and Criminal Investigations
Mir-Com Products LLC 9/11/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Via United Parcel Service
September 11, 2012
Geoffrey T. Miscoe
Mir-Com Products LLC
299 Main Street
Central City, PA 15926
Dear Mr. Miscoe:
During an inspection of your firm located in Central City, Pennsylvania, on June 7, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Kennedy Decompression Technique (KDT) and KDT Neural-Flex devices and distributes the K-Laser USA device. 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 the KDT and KDT Neural-Flex 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. We received a response from your firm dated June 19, 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. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm does not have established corrective and preventive action procedures.
2. 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 established purchasing control procedures.
3. 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 maintain a complaint file, nor are there any complaint handling procedures.
4. Failure to ensure that management with executive responsibility establishes its policy and objectives for, and commitment to, quality; and failure to ensure that management with executive responsibility ensures that the quality policy is understood, implemented, and maintained at all levels of the organization, as required by 21 CFR 820.20(a). For example, your firm has no established quality policy or quality objectives.
5. Failure to establish procedures for quality audits and 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 CFR 820.22. For example, your firm does not have an established quality audit procedure, nor have there been any quality audits performed.
6. Failure to maintain device master records (DMR) and ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181. For example, device master records for the KDT and KDT Neural-Flex devices are not maintained.
7. Failure to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part, as required by 21 CFR 820.184. For example, device history records for the KDT and KDT Neural-Flex devices are not maintained.
8. Failure to maintain a quality system record that includes, or refers to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device, including, but not limited to, the records required by 21 CFR 820.20, as required by 21 CFR 820.186. For example, a quality system record is not maintained.
We reviewed your firm’s response and conclude that it is not adequate. The response did not provide any specific plan or evidence of any corrections, corrective actions, and systemic corrective actions to address these observations. Your firm states that Mir-Com products, LLC, manufactures nothing, but only distributes other manufacturers’ registered and cleared products. However, the inspection revealed that Mir-Com products, LLC, is a specification developer and therefore subject to the current good manufacturing practice requirements.
Your firm markets the KDT and KDT Neural-Flex devices, which consist of a powered or non-powered chiropractic table, KDT 600 or KDT 650, provided by Armedica Manufacturing Corporation, and a programmable or nonprogrammable traction unit, MTD 4000 or Accutrac, provided by Mettler Electronics Corporation and I-REP, Inc. A review of our records indicates that Armedica Manufacturing Corporation has a powered table that is cleared as K981539 under section 510(k) of the Act, 21 U.S.C. § 321 360(k). The MTD 4000 for Mettler Electronics Corporation is cleared as K091540 under section 510(k) of the Act and the Accutrac Traction device for I-REP, Inc., is cleared under section 510(k) of the Act as K930691. However, the KDT and KDT Neural-Flex System are considered multi-function physical therapy tables as defined in 21 CFR 890.5880 and, therefore, are Class II devices requiring 510(k) clearance based on modifications to these devices, as described under 21 CFR 807.81(a)(3)(i).
A review of our records also indicates that we cleared a premarket notification (510(k)) for the K-Laser USA device as the K-Series Class IV Therapeutic Laser (K091497) with indications for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for:
• Temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis
• Promoting relaxation of the muscle tissue
• Temporarily increase local blood circulation
However, the information in the Bryanne Enterprise, Inc., 2012 Product Catalog, includes the following claims for the K-Series Class IV Therapeutic Laser:
• Patients who have not responded well to surgery or drug therapy
• Conditions not currently treated at your facility
• Pain associated with Soft Tissue Injuries
• Back Pain and Spinal Conditions
• Cervical Neck Pain
• Carpal Tunnel Syndrome
• Myofascial Trigger Points
• Epicondylitis (Tennis Elbow)
• Sprains, Strains
• Repetitive Motion Injuries
• Plantar Fascitis
Promotion of these devices with claims other than those cleared in the 510(k) premarket notification, including the above claims, represents a major change or modification in the intended use of your device that requires a new premarket notification under 21 CFR 807.81(a)(3)(ii).
Based on these findings, the KDT and KDT Neural-Flex devices and the K-Laser USA device 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). These devices are also misbranded under section 502(o) 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) 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.
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 2012.
Therefore all of your firm’s devices are misbranded within the meaning of section 502(o) 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 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.
Please notify this office in writing within fifteen (15) 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: U.S. Food and Drug Administration, U.S. Customhouse, Room 900, 2nd St. and Chestnut St., Philadelphia, PA 19106, Attn: Yvette Johnson, Compliance Officer. Refer to the Unique Identification Number CMS case 318959 when replying. If you have any questions about the contents of this letter, please contact: Yvette Johnson at 215-717-3077 or Yvette.Johnson@fda.hhs.gov.
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.