Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
May 30, 2014
Ref: 2014-DAL-WL - 07
VIA UNITED PARCEL SERVICE
Douglas J. Durning, Chairman and Chief Executive Officer
9636 North May Avenue, Suite 230
Oklahoma City, OK 73120
Dear Mr. Durning:
During an inspection of your firm located in Oklahoma City, Oklahoma, on December 10, 2013 through December 13, 2013, an Investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures and distributes the PN-1000 electrical stimulator 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 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. We received your response dated December 19, 2013 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish procedures for corrective and preventive actions as required by 21 CFR 820.100(a).
For example, your firm did not have any written procedures for corrective and preventive actions.
2. Failure to establish procedure for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a).
For example, your firm did not have any written procedures that describe how complaints will be received, reviewed, evaluated, and documented by your firm. Further, we observed twenty one complaints of devices failing to meet specifications that did not have documented investigations or documented evaluations identifying no investigation was required.
3. Failure to establish 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 has a contract specification developer and manufacturer for your PN-1000 device; however, you have no procedures that describe how your supplier and contractors will be selected and evaluated; how the extent and type of control will be determined; and how this information will be documented. You stated during the inspection you perform several visits to your contract manufacturer (b)(4) to evaluate their quality system; however, you had no procedures that identify what is covered or reviewed during these visits, and you had no documentation of the findings of those visits.
4. Failure to establish procedures to control product that does not conform to specified requirements as required by 21 CFR 820.90(a).
For example, your firm does not have written procedures for the control, review, disposition, and documentation of products that do not meet specified requirements.
5. Failure to maintain a device master record (DMR) as required by 21 CFR 820.181.
For example, your firm has not established a DMR for your PN-1000 device.
6. Failure to maintain all acceptance records as part of the device history record (DHR) as required by 21 CFR 820.80(e).
For example, thirty (30) DHRs were reviewed during the inspection. All of the DHRs reviewed were deficient in that they were either missing the Unit Check Station Sheet or they contained incomplete Unit Check Station Sheets.
7. Failure to establish procedures for quality audits as required by 21 CFR 820.22.
For example, your firm has not established procedures for quality audits and you have not conducted any quality audits of your quality system since your firm was founded in 2008.
8. Failure to establish document control procedures as required by 21 CFR 820.40.
For example, you firm does not have any written document control procedures. Further, our inspection found the procedures available in your firm’s manufacturing area were obsolete and contained several handwritten changes that were not dated or signed by an approving official.
We have reviewed your firm’s response dated December 19, 2013 and have determined the response is inadequate. In general, although you have committed to establishing the required procedures you did not provided the expected timeframes for their completion and you did not provide any copies of the procedures for our review. In addition, you did not provide sufficient details of the planned corrective actions to allow for a complete evaluation of the proposed corrective actions at this time. Also, your response does not adequately address how you will retroactively review deficient records to identify and correct the all deficient records. For example, although you have committed to established new complaint procedures moving forward; your response does not address how you will review all previously received complaints to ensure all deficient complaint records are identified and corrected where possible.
MEDICAL DEVICE REPORTING
Our inspection also revealed that your firm’s PN-1000 electrical stimulator devices are 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. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement adequate written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
For example, your firm did not have written MDR procedures.
We reviewed your firm’s response and conclude that it is not adequate. Your response states you have conducted training for your staff. However, your procedures have not been documented. In addition, your response does not indicate how you will review previously received complaints to verify they were appropriately reviewed and evaluated for MDR reportability.
FDA has reviewed your website, www.neurolumen.com, and determined that the PN-1000 electrostimulator 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) for the device as described and marketed. The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
Specifically, you have modified the PN-1000 cleared under K082223 with wavelengths at (b)(4) nm, by adding wavelengths at (b)(4). These modifications to light wavelength can significantly change the light interaction and affect the safety of the device. Therefore, a new 510(k) is required.
In addition, your firm’s website includes the following statement:
“Once the wraps are in place, the control unit provides up to 30 minutes of simultaneous transcutaneous electrical nerve stimulation (TENS), low-level laser therapy and light-emitting diode (LED) therapy.”
During the initial submission, your firm did not explicitly state that the transcutaneous electrical nerves stimulator (TENS), LED, and laser modalities would be used simultaneously to treat patients. Since the combined therapy has different risks than each used independently, a 510(k) would be required to evaluate the combined use.
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/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Our office requests that Neurolumen, LLC immediately cease activities that result in the misbranding or adulteration of the Neurolumen PN System Model 1000, such as the commercial distribution of the device for the uses discussed above.
A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.
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 (which must address systemic problems) 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: Dallas District Office, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the contents of this letter, please contact: Jeff R. Wooley, Compliance Officer at 214-253-5251.
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.
Reynaldo R. Rodriguez, Jr.
Dallas District Director