Medical Quant USA 1/9/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Cincinnati District Office|
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
January 9, 2012
WARNING LETTER CIN-12-248774-09
Mr. Max Kanarsky
Medical Quant USA
6565 Cochran Road
Solon, Ohio 44139
Dear Mr. Kanarsky:
During an inspection of your firm located in Solon, Ohio,on August 15, 2011, through September 2, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the MR4, MR4 Activ, TQ Solo, and TQ Solo Pro Infrared Lamps. 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 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 and maintain procedures for implementing Corrective and Preventive Actions (CAPA), as required by 21 CFR 820.100(a). The inspection revealed that your firm does not have a written procedure for CAPA.
2. Failure to document the acceptance or rejection of incoming product, as required by 21 CFR 820.80(b). For example:
a) On or about 4/14/11, your firm received 78 MR4 units from (b)(4);
b) On or about 5/5/11, your firm received 500 TQ Solo units from (b)(4);
c) On or about 2/7/11, your firm received 27 MR4 Activ units from (b)(4)
There is no documentation for the acceptance or rejection of the cited incoming product.
3. Failure to maintain a record that includes the reason and name of the individual responsible for the decision not to investigate a complaint, as required by 21 CFR 820.198(b). For example, there is no record documenting the reason that no investigation was made and the name of the individual responsible for the decision not to investigate the following complaints:
a) A TQ Solo device was returned for warranty service on 3/22/11;
b) A TQ Solo device was returned for failing to pass a self-test on 4/15/11.
4. Failure to establish and maintain adequate procedures for purchasing controls to include, where possible, an agreement that suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service, as required by 21 CFR 820.50(b). For example:
a) Your firm’s exclusive License and Distribution Agreement between Medical Quant USA and (b)(4), does not specify that the supplier will notify you of any changes in the product;
b) Your firm’s agreement between Medical Quant USA and (b)(4), does not specify that the supplier will notify you of any changes in the product.
5. Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2).
The inspection revealed that your firm occasionally conducts rework on returned devices by realigning the emitter; however, there is no procedure in place to cover any rework performed by Medical Quant USA employees.
6. Failure to ensure that labeling, including operating manuals, is not released for storage or use until a designated individual has examined it for accuracy, and that the release is documented in the Device History Record, as required by 21 CFR 820.120(b).
Section 3.3 of your Labeling Procedure (SOP-109-01) requires the review of all labeling by Quality Assurance to ensure that it is consistent with the approved product claims and intended use. During the inspection, your firm stated that there is no documentation that any of the advertisements, marketing materials, manuals, or Web site content is reviewed or approved prior to publication or distribution.
7. Failure to establish and maintain adequate procedures to ensure that documents, or changes to documents, are approved prior to issuance, and that such documents include the date and signature of the individuals approving the documents, as required by 21 CFR 820.40(a).
There is no documentation that the following documents were ever approved:
a) Complaint Handling Procedure (SOP 106-01);
b) Distribution Records Procedure (SOP-102-01);
c) Returned Goods Procedure (SOP-104-01);
d) Labeling Procedure (SOP-109-01).
8. Failure to establish procedures for identifying training needs and to ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25.
The inspection revealed that your firm does not have a formal training program, and that there is no documentation of any training taken by Medical Quant employees.
During the inspection, FDA also collected and reviewed the following labeling for these devices, and found that you are promoting and marketing the devices without the required marketing clearance or approval, in violation of the Federal Food, Drug and Cosmetic Act (the Act):
- MR4 Operating Manual; MR4 Treatment Protocol Manual; MR4 Operating Guide;
- MR4 Activ Operating Manual; MR4 Activ Treatment Protocol Manual; MR4 Activ Protocol Manual;
- TQ Solo Operating Manual; TQ Solo Treatment Protocol Manual
The MR4, MR4 Activ, TQ Solo, and TQ Solo Pro devices were cleared for over-the-counter use under K080102 for the following:
Indications for Use: All four devices are indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
However, the Operating Manual (USA Version) for the MR4 Activ and other manuals make the following clinical and biological effects claims for these devices:
“Clinical Effects: Immune Development; Analgesic Effect; Local Anesthesia; Regeneration of the Damaged Tissues; Synthesis of Epithelium and Skin Regeneration; Improvement of Blood Circulation; Improvement of Blood Composition; Anti-Inflammatory Action; Anti-Edematous Action; Improvement in Tissue Nutrition; Increase in pain threshold; Improvement of Microcirculation.”
“Biological Effects: The activation of protein synthesis (RNA, DNA); The increase of enzymatic formation and activation; The development of nerve fiber conductivity; The normalization of specific and non-specific immune factors; The increase of adenosine triphosphate (ATP) formation; Cholesterol Decrease; The normalization and synthesis of prostaglandan [sic]; A decrease of peroxidation of lipids; The strong antioxident [sic] effect; The influence on cutaneous receptors; The amplification of the laser penetration into tissues; The improvement of the cellular potential”.
Furthermore, your web site at www.multiradiance.com states, “Laser Therapy is an effective treatment modality for a wide range of indications . . . .” Below are examples excerpted from your website when last accessed on December 28, 2011:
- Achilles tendinitis
- Herpes Simplex
- Oral mucositis
- Leg ulcers
- Bed sores
The uses and indications described above have not been cleared by FDA and represent major changes or modifications in the intended use of the devices.
These changes to the intended use of the MR4, MR4 Activ, TQ Solo, and TQ Solo Pro devices cause these devices to be 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) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its 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 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/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 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: Cincinnati District Office. Please refer to Warning Letter #CIN-12-248774-09 when replying. If you have any questions about the contents of this letter, please contact: Stephen J. Rabe at the address listed in this letterhead. If you have questions about this letter you may contact Mr. Rabe at 513-679-2700 ext 2163.
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.
Paul J. Teitell