Inspections, Compliance, Enforcement, and Criminal Investigations
EM Probe Inc. 05-Oct-07
Department of Health and Human Services
Public Health Service
October 5, 2007
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-01
Glen A. Gordon, M.D.
4110 NE Carver Road
Port Gamble, Washington 98364
Dear Dr. Gordon:
During an inspection of your firm located in Port Gamble, Washington on May 17 through 22,2007, an investigator from the United States Food and Drug Administration FDA) determined that your firm manufactures the EM-pulse Trilogy and the EM-pulse Solo. 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.
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 manufacturing, packing, storage, or installation are not in conformance 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. We received three(3) responses from you dated May 29, 2007, June 28, 2007, and September 7, 2007, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to you. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to the following:
1. Failure to establish a quality plan which defines the quality practices, resources, and activities relevant to the device, as required by 21 CFR 820 .20(d). You could not present a quality plan during the inspection when requested. In your response dated September 7, 2007, you provided an updated quality plan from the one you submitted in your June 28, 2007, response. We noted that the testing requirements in the updated plan were not consistent with the submitted procedures for acceptance criteria. Your plan also stated that the devices will be produced and tested by assemblers, but you don't address how you will monitor the assemblers and retain testing documentation from them.
2. Failure to establish policy and objectives for, and commitment to quality by management with executive responsibility, as required by 21 CFR 820.20(a). You could not present any documents related to management responsibilities for review during the inspection. In your response dated September 7, 2007, you provided a document titled "Management Representative." In this document, you identified who the management representative will be, but you have not addressed what specific responsibilities and authority this representative will have in this proposed structure.
3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). You stated to our investigator during the inspection that you have not documented CAPA procedures and have never maintained CAPA files.
4. 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 CFR 820.30(a). You had no documented design control procedures during the inspection even though you had contracted to have the EM-pulse Trilogy and EM-pulse Solo produced for you also marketed and distributed these devices since February 2004. You had. In your response dated September 7, 2007, you submitted proposed procedures but they don't specify the documentation that is required for the design activities.
5. Failure to establish and maintain a design history file for each device as required CFR 820 .30(j) by 21. You did not have a design history file for either the EM-pulse Trilogy EM-pulse Solo devices at the time of the inspection. In your response dated September 7, 2007, you provided your design plan procedure which does not specifically address the design history file.
6. Failure to establish procedures to ensure that device history records for each batch, unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the Quality Systems regulation as required by 21 CFR 820.184. During the inspection, our investigator noted that since February 2004, you had distributed the EM-pulse Trilogy and EM-pulse Solo devices with no procedures in place for device history records. In your response dated September 7, 2007, you provided to us some documents, but they do not address how you plan to track and document device history records. Since each device is not marked, it is unclear how you will link the acceptance activities and testing results to each device.
7. Failure to establish and maintain procedures for acceptance criteria, as required by 21 CFR 820.80(a). During the inspection, our investigator noted that since February 2004, you had distributed the EM-pulse Trilogy and EM-pulse Solo devices with no procedures in place for acceptance of finished products. Also, you had failed to maintain documentation for the testing conducted on these devices, as required by 21 CFR 820.80(e). In your response dated September 7, 2007, you provided acceptance criteria, but your response does not provide documentation for recording acceptance activities. Also, the acceptance criteria do not specifically include the control and disposition of nonconforming products and rework activities.
8. Failure to establish procedures to ensure that the equipment is routinely calibrated, inspected, checked, and maintained and to ensure that these activities are documented, as required by 21 CFR 820 .72(a). During the inspection, you were using a oscilloscope in your facility without any procedures in place you mention. In your response dated September 7, 2007, calibration of test equipment under the production and process controls, but you do not require any documentation to record calibration activities.
9. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and 820.50; services conform to specified requirements, as required by 21 CFR. You have a contract with a manufacturer to produce the EM-pulse Trilogy and the EM-pulse Solo devices, but there is no documentation of the quality requirements you require of this manufacturer. During the inspection, you stated that you test every device and have had very few that fail final acceptance testing but you have not defined and documented the quality requirements. Also, the certification of your contract manufacturer which you provided to our investigator expired in October 2006. In your response dated September 7, 2007, you only mention that you use [redacted] certified assemblers and they are thoroughly investigated. You do not require any documentation to record these activities.
10. Failure to have management review of the suitability and effectiveness of the quality system, as required by 21 CFR 820 .20(c). You have not established a management review procedure or documented a review meeting, but you have manufactured and distributed devices. In your responses dated June 28, 2007, and September 7, 2007, you provided two documents to address this issue, the "Management Review Procedure", and "Management Review Form." These documents do not assure us that they will provide a complete review of the suitability and effectiveness of the quality system. The procedure states that the purpose for the review procedure is to ensure that the requirements of the "Quality policy" are met but the Quality Policy is not defined.
11. 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. You could not provide any documented quality audit procedures during the inspection. In your responses dated June 28, 2007, and September 7, 2007, you did not address conducting a "re-audit" to determine if any deficient matters have been corrected. Also, your "Quality Audit Procedures" do not address if the audit will be conducted by someone who does not have direct responsibility for the area being audited.
Our inspection also revealed that the EM-pulse Trilogy and the EM-pulse Solo are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 3S1(f)(1)(B), because you do 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)9 for claims you are making for the device or an approved application for an investigational device exemption(IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g).The EM-pulse Trilogy and EM-pulse Solo are also misbranded under section 502(o) of the Act 21 U.S.C. in the 352(o), in that a notice or other information respecting a major change or modification in the intended use of the the EM-pulse Trilogy and the EM-pulse Solo was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k), and 21 CFR 807.81(a)(3)(ii): 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), Part 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 FDA will evaluate the information you submit and decide whether your product may be legally marketed. The premarket notification, K024361, for EM-Probe states that "The EM-PROBE is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, and to increase local blood circulation." Your labeling for these devices collected during the inspection, however, contains new intended uses, such as treatment for backache, carpal tunnel syndrome, sciatica, and fractures and statements that your devices have been found to be superior to drugs in the treatment of many of these conditions.
Your website dated August 9, 2007, www.em-probe.com, also contains new intended uses, such as:
• "Fast Relief From Pain & Inflammation Without Drugs!"
• "TREAT*** Arthritis ***Bruises *** Swelling *** Sprains *** Cuts *** Trauma"
•"Stops inflammation faster than any drug or other technology"
• "Example: fracture healing in 10-12 days instead of six weeks"
"EMpulse *** Spectrum of Use *** Mammation/Pain *** Bites, stings, trauma ***
Arthritis, muscle injury *** Neuritis, neuropathy *** Carpal tunnel *** Pain Relief *** Tissue healing *** Menses and childbirth *** Tissue Restoration *** Nerve repair *** Fracture healing *** Prosthesis stabilization *** Myocardial ischemia, congestive failure *** Cerebral ischemia, stroke *** Spinal Cord Injury"
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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. Additionally premarket approval applications for Class III devices to which the Quality System 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 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 violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned cortrections will occur over time, please include a timetable for implementation of corrections. If corrective action cannot be completed within 15 working days, state the for the delay and the time within which the corrections will be completed.
Your response should be sent to the Food and Drug Administration, Attention Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421: Lisa M. Elrand at (425) 483-4913.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) 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 the violation(s), and take prompt actions to correct the violations(s) and to bring your products into compliance.
Charles M. Breen