Inspections, Compliance, Enforcement, and Criminal Investigations
Suarez Corporation Industries, Inc. 20-Aug-08
Department of Health and Human Services
Public Health Service
Cincinnati District Office
August 20, 2008
VIA FEDERAL EXPRESS
Mr. Benjamin D. Suarez
Suarez Corporation Industries, Inc.
dba Biotech Research
7800 Whipple Avenue NW
Canton, Ohio 44720
Dear Mr. Suarez:
During an-inspection of your firm, located in Canton, Ohio, on March 4 through 24, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is the manufacturer or initial distribution of the following devices: PainNOT Infrared Heating Pads, Foot Choice Infrared Heat Vibrating Massager, and ThermotexTM TTS Infrared Heating Pads. 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.
Additionally, your firm is the importer and own-label distributor of the PainNOT Patch, an over-the-counter (OTC) drug that your firm labels as a topical analgesic. The PainNOT Patch meets the definition of a drug as defined in section 201(g) of the Act, 21 U.S.C. § 321(g), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
We received a response on your behalf from Michael R. Puterbaugh, Corporate Counsel, dated April 14, 2008, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you at the close of the inspection. We address his response below in relation to each of the noted violations.
FDA's inspection of your firm revealed that the PainNOT Heating Pad, the Foot Choice Infrared Heat Vibrating Massager, and the ThermotexTM TTS Infrared Heating Pads (Models: Platinum, Platinum Plus, Gold, Elbow, Shoulder, Wrist, Knee, and Professional) are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because neither you, as importer of record, nor the foreign manufacturers 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(o) of the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce these 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) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. Title 21, Code of Federal Regulations (CFR), section 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your devices is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html.
The inspection further revealed that the PainNOT Infrared Heating Pad, Foot Choice Infrared Heat Massager, and ThermotexTM Heating Pad devices are also 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 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
1. Failure to submit an MDR to FDA, with a copy to the device's manufacturer, within 30 days of receiving information that reasonably suggests that your marketed device may have caused or contributed to a serious injury. [21 CFR § 803.40(a)] For example:
PainNOT Infrared Heating Pad
On 3/23/06, Customer #[redacted] complained that her husband received third degree burns because he was not warned that the device used infrared heat. Your firm did not submit an MDR to FDA or the manufacturer.
On or about 1/23/05, Customer #[redacted] complained that the heating pad caused second degree burns on his upper back and required treatment in an emergency room. Your firm did not submit an MDR to FDA or the manufacturer.
Foot Choice Infrared Heat Massager
On or about 3/19/07, Customer #[redacted] complained that the infrared massager caused severe burns on the soles of her left and right feet that resulted in the need for medical intervention and hospitalization. Your firm did not submit an MDR to FDA or the manufacturer.
On or about 1/17/07, Customer #[redacted] complained that the infrared massager caused acute pains in the arch of her feet and big toe joints. She also developed a bunion on a toe on her right foot which required medical attention and surgery. Your firm did not submit an MDR to FDA or the manufacturer.
On or about 3/27/06, Customer #[redacted] complained that the infrared massager caused burns on the bottom of his feet that required treatment by a doctor. Your firm did not submit an MDR to FDA or the manufacturer.
On or about 7/1/06, Customer #[redacted] complained that the infrared massager caused blisters on the bottom of his feet that required medical treatment. Your firm did not submit an MDR to FDA or the manufacturer.
On or about 7/5/06, Customer #[redacted] complained that the infrared massager caused sores on the soles of his feet and he sought medical attention. Your firm did not submit an MDR to FDA or the manufacturer.
ThermotexTM Heating Pad
On or about 3/28/07, Customer #[redacted] complained that the heating pad caused injuries, and he incurred medical and hospital expenses due to these injuries. Your firm did not submit an MDR to FDA or the manufacturer.
We have reviewed your response and have concluded that it is not adequate because it does not address whether you have reported these complaints to FDA on FDA Form 3500A as MDR events and copied the device's manufacturer. Additionally, your response does not address how your, fit interviews, its customer database to determine if there are other MDR reportable events.
2. Failure to develop, maintain, and implement written MDR procedures, [21 CFR § 803.17]
Your response states that you are still in the process of developing an MDR procedure. Please provide a copy of this procedure when it has been completed.
Our inspection further revealed that your Foot Choice Infrared Heat Massagers are also misbranded within the meaning of 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 806 - Reports of Correction and Removals regulation. Significant deviations include, but are not limited to the following:
Failure to submit a written report to FDA regarding the correction that your firm made to the Foot Choice Infrared Heat Massager as required by 21 CFR § 806.10. Between August 9 and 16, 2006, your firm sent a letter to customers warning them to, "Check the skin in contact with the heated area of Foot Choice frequently to reduce the risk of bums or blistering." This letter also included instructions on how to reduce the risk of fire, electrical shock, and injury. These letters were sent because your firm recognized, based on the number of burn complaints it received, that temperature settings on the infrared heating sources were too high and could cause serious burns. This correction was initiated to remedy a problem with the device which may present a serious risk to health.
Your response states that you are developing a corrections and removals procedure. Please provide a copy of this procedure to FDA for review.
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 manufacturing, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 CFR Part 820. These violations include, but are not limited to, the following:
1. Failure to establish procedures for implementing corrective and preventive actions. [21 CFR § 820.100]
For example, you are the initial importer of medical devices, but you have not established written corrective and preventive action procedures.
We have reviewed your response and have concluded that it is not adequate because it does not address this violation; rather, your response addresses 21 CFR Part 806 - Correction and Removals.
2. Failure to identify actions needed to correct and prevent the recurrence of nonconforming product and other quality problems. [21 CFR § 820.100(a)(3)]
For example, on 6/29/06, your firm stopped distributing the Foot Choice Infrared Heat Massager after you received multiple complaints relating to serious burns. You sent the remaining stock of devices (over 19,000 units) back to the manufacturer in [redacted] for rework, which required lowering the temperature setting of the infrared heat source. You did not perform a health hazard evaluation to determine if further corrective action should be taken for the products that had been distributed.
Your response regarding this observation cannot be evaluated at this time, because it states that you are in the process of gathering information to determine the impact/risk of the remaining products on the market. Please provide a copy of your assessment and any corrective actions that you plan to take, so we may determine their adequacy.
3. Failure to establish complaint handling procedures that ensure the following: All complaints are processed in a uniform and timely manner; oral complaints are documented upon receipt; and all complaints are evaluated, investigated, and appropriate corrective actions are taken. [21 CFR § 820.198]
For example, your General Manager stated that you do not have any written complaint handling procedures and you do not maintain complaint files.
4. Failure to review, evaluate, and investigate complaints involving the possible failure of a device. [21 CFR § 820.198(c)]. For example, you did not perform an investigation for the following:
• 35 complaints from customers stating they received burns on their feet as a result of using the Foot Choice Infrared Massager.
• 18 complaints from customers stating they received burns while using the Thermotex Heating Pad.
• 7 complaints from customers stating they received a burn as a result of using the PainNOT Heating Pad.
• 46 complaints from customers stating they detected a burning smell while using the Foot Choice Infrared Massager.
• 2 complaints from customers stating they detected a burning smell while using the Thermotex Heating Pad.
In addition to the devices discussed above, our inspection revealed that your firm also imports and distributes the PainNOT Patch, a product that bears your company's name and phone number on its labels. The investigator obtained copies of the immediate container label and promotional labeling of the PainNOT Patch, which includes the following examples of therapeutic claims and active ingredients described in PainNot Patch's labeling:
• "Active Ingredients ... Menthol 5% ... Methyl Salicylate 2.66% ... Borneo Camphor ...2.66% ... Camphor, Thymol 1% ... Diphenhydramine Hydrochloride 0.66% ... Capsicum extract 0.25% ...."
• "Pain Relieving Patch ... For temporary relief of minor aches & pains ... Works in 10 minutes to relieve pain ...."
• "Relieves pain from arthritis, backache, bruises, sprains and strains ....
• "Relieves pain from arthritis, back, bursitis, carpal tunnel, tendonitis, sprains, strains, and more ...."
• "Not only is the PainNOT Patch safe to use, but, it also helps the body carry toxins away from the damaged area causing the pain ...."
The PainNOT Patch's label makes clear that the product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Accordingly, the PainNOT Patch is a drug under section 201(g) of the Act, 21 U.S.C. § 321(g).
FDA's inspection revealed that your firm has significant deviations from the CGMP requirements for drugs, see 21 CFR Parts 210 and 211. These cGMP deviations make the PainNOT Patch adulterated within the meaning of Section 501(a)(2)(B) of the Act, 21 U.S.C. § 351(a)(2)(B). The significant drug CGMP violations observed during the inspection include, but are not limited to, the following:
1. Failure to establish and follow procedures describing the handling of written and oral complaints regarding a drug product. [21 CFR § 211.198(a)]
For example, your firm does not have a written complaint procedure for the PainNOT Patch.
2. Failure to keep complete written records of complaints, including findings of an investigation and follow-up or documenting the reason an investigation was deemed to be unnecessary. [21 CFR § 211.198(b)]
For example, your firm received the following complaints for the PainNOT Patch for which you have no records regarding investigation and follow-up:
• 100 complaints where the customers stated they were allergic to the product.
• 99 complaints where the customers stated they received rashes from the product.
• 20 complaints where the customers stated they received burns from the product.
In addition to the CGMP violations noted above, the PainNOT Patch is-a "new drug" as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective (GRAS/E) for its labeled claimed indications. Accordingly, marketing of the PainNOT Patch in the United States violates section 505(a) of the Act, 21 U.S.C. § 355(a), which prohibits introduction or delivery for introduction into interstate commerce of a new drug unless an FDA-approved application is in effect for the drug. Section 301(d) of the Act, 21 U.S.C. § 331(d), makes the introduction or delivery for introduction into interstate commerce of any article that violates section 505 a prohibited act.
Given the serious nature of your violations of the Act, your devices and drug product are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will determine the adequacy of your response during a future inspection of your firm.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in the initiation of regulatory action without further notice. This may include, but is 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. Additionally, premarket applications for Class III devices to which the QS regulation deviations 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 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 violations, from occurring again. Include documentation of the corrective actions you have taken. If your planned corrective actions will occur over time, please include a timetable for implementation of these 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 Ms. Gina Brackett, Compliance Officer, Food and Drug Administration 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, you may contact Ms. Brackett at (513) 679-2700, ext. 167, or you may send a facsimile to her at (513) 679-2773.
Finally, you should know that this letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by the FDA. The specific violations noted in this letter and in the FDA 483 may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt action to correct the violations and to bring your products into compliance.
Toniette K. Williams
Acting District Director
1 Some drug products intended for indications such as those promoted for PainNOT Patch are evaluated under the Tentative Final Monograph (TFM) for OTC External Analgesics, published in the Federal Register on February 8, 1983 (48 Fed. Reg. 5852). The PainNot Patch does not fit within the TFM for several reasons. First, the TFM did not include "diphenhydramine hydrochloride" or "camphor, thymol" as GRAS/E active ingredients for counterirritant use. Second, the TFM did not include the particular combination of ingredients declared on the PainNot Patch's labeling, nor was such combination evaluated in the developing TFM. Third, certain of the PainNot Patch's labeled indications, such as bursitis, carpal tunnel, and tendonitis, are not addressed in the TFM. We are unaware of any OTC product formulated and labeled as the PainNOT Patch having been available in the U.S. market on or before December 4, 1975. Thus, this product is not deferred to the OTC Drug Review and is, therefore, a "new drug."