- Cenorin, LLC
- Issuing Office:
- Seattle District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021-4425
February 12, 2015
In reply refer to Warning Letter SEA 15-09
F. Richard Radford, Chief Executive Officer
6324 South 199th Place, Suite 107
Kent, Washington 98032-2135
Dear Mr. Radford:
During an inspection of your firm located at 6324 South 199th Place, Suite 107, Kent, Washington, on April 9 through May 2, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Medical Device Cleaning and High Level Disinfection (HLD) Washer/Pasteurizer System Model 610 device. Under section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 321(h)], this product is a device because it is 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 function of the body.
Our inspection revealed that your firm’s Medical Device Cleaning and HLD Washer/Pasteurizer System Model 610 device is 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, as required under section 519 of the Act [21 U.S.C. § 360(i)], and Title 21, Code of Federal Regulations (CFR) Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
1. Failure to submit a written report of a correction or removal of a device initiated to reduce a risk to health posed by the device, or to remedy a violation of the Act caused by the device, which may present a risk to health, as required by 21 CFR 806.10. For example, your firm notified customers in order to address two failure modes related to your Medical Device Cleaning and HLD Washer/Pasteurizer System Model 610 device.
Specifically, on January 24, 2013, your firm distributed letters to customers requesting they initiate a daily procedure to assure the temperature control system is working properly. On December 23, 2013, your firm distributed a second customer notification letter notifying your customers of the possible false temperature sensor readings and failure to pasteurize. The letter also informed customers that an upgrade was available to mitigate the temperature sensor issue. On April 24, 2014, your firm distributed a customer notification letter notifying the customers of the possible cleaning fluid pump failure, which may cause your Medical Device Cleaning and HLD Washer/Pasteurizer System Model 610 device to not achieve the desired level of debris reduction. The letter provided the customers with two options to help mitigate the potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle.
Your firm failed to notify the FDA of the medical device correction or removal, and did not provide the information required by 21 CFR 806.10. Your firm’s actions have been reviewed by FDA and determined to meet the definition of a Class II Recall, which also meets the risk to health threshold for a 21 CFR Part 806 report, as specified in 21 CFR 806.10. Therefore, your firm’s actions should have been reported to the FDA.
We have reviewed your response, dated May 21, 2014, to the FDA 483, Inspectional Observations, issued to your firm at the close of the inspection. You have not included in this response any actions you have taken, or plan to take, to prevent this violation from recurring.
Our inspection also revealed that your Medical Device Cleaning and HLD Washer/Pasteurizer System Model 610 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)]. Your Medical Device Cleaning and HLD Washer/Pasteurizer System Model 610 device is also misbranded under section 502(o) of 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 in that a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k) of the Act [21 U.S.C. § 360(k)], and 21 CFR 807.81(a)(3)(i) (requiring a premarket notification submission for a “change or modification in the device that could significantly affect the safety or effectiveness of the device….”). Specifically, your firm has modified your Medical Device Cleaning and HLD Washer/Pasteurizer System Model 610 device, cleared under K810311, as follows:
1. Your firm discovered that the temperature sensor/control system in the Medical Device Cleaning and HLD Washer/Pasteurizer System Model 610 device may provide a false temperature reading and initiated and completed a CAPA Root Cause Analysis. As a result, users were informed of a recommended daily procedure to assure the temperature control system was working properly, which was followed by a software upgrade to the
system that would automatically alert the user if there was a temperature error of this type.
2. Your firm discovered through complaints that there was a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction. To address the failure, your firm redesigned the cleaning fluid system.
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, as set forth in 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm
. The FDA will evaluate the information you submit and decide whether your 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.
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: Seattle District Office, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4425. Refer to the Warning Letter SEA 15-09 when replying. If you have any questions about the contents of this letter, please contact: LCDR Cynthia White, Compliance Officer at (425) 302-0422.
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 the FDA. The specific violations noted in this letter and in the FDA 483, Inspectional Observations, 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.
Miriam R. Burbach