Inspections, Compliance, Enforcement, and Criminal Investigations
O'Ryan Industries, Inc. 06-Aug-08
Department of Health and Human Services
Public Health Service
August 6, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning. Letter SEA 08-28
Rick D. Grant, President
O'Ryan Industries, Inc.
12711 NE 95th Street
Vancouver, Washington 98682
Dear Mr. Grant:
During an inspection of your firm located at 12711 NE 95th Street, Vancouver, Washington, on April 28-30, 2008, and May 13, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the ENDO 150 endoscopic light source, and imports the Omega ST Sterilizer (autoclave). 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.
As explained below, our review of these documents and of agency records of premarket review decisions, indicates that your devices are adulterated under section 501(f)(1)(B) of the Act [21 U.S.C. 351(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), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act 21 U.S.C. 360(g). These 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 is deemed satisfied when a PMA is pending before the agency (21 U.S.C. 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 on whether your product may be legally marketed.
This inspection also 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) regulations found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. Our investigator's observations were. presented on a Form FDA 483, List of Inspectional Observations, that was issued to you on May 13, 2008. These violations include, but are not limited to the following:
Quality System Regulation
1. Failure to have management with executive responsibility to establish its policy and objectives for, and commitment to, quality. Management shall ensure that the quality policy is understood, implemented, and maintained at all levels of your organization as required by 21 CFR 820.20. Specifically, you have failed to establish quality system procedures and instructions per 21 CFR 820.20(e); to have a management representative who has been appointed to ensure that the quality system requirements are met per 21 CFR Part 820.20(b)(3), and to have a management representative who will review the suitability and effectiveness of the quality system per 21 CFR 820.20(c). You have manufactured and distributed approximately [(b)(4)] units of your ENDO 150 endoscopic light source, and you have distributed approximately [(b)(4)] Omega ST Sterilizers (autoclave) without any quality system procedures in place at your firm.
2. 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 have been manufacturing and distributing devices since April 1, 2006, and you have never conducted a quality audit.
3. Failure to implement a written procedure to control product that does not conform to specified requirements, as required by 21 CFR 820.90. Furthermore, you have no procedures to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a).
4. Failure to ensure that all inspection, measuring, and test equipment; including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes, and is capable of producing valid results, as required by 21 CFR 820.72(a).
5. Failure to establish and maintain procedures for acceptance activities, such as inspections, tests, or other verification activities, as required by 21 CFR 820.80(a). You have not established acceptance activities for your ENDO 150 endoscopic light source device that you have manufactured and distributed, and for those that were being stored at your facility during the time of the inspection. Furthermore, you have failed to document acceptance activities, as required by 21 CFR 820.80(e).
6. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a), and failure to establish a procedure addressing the analysis of sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a)(1).
7. Failure to establish procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a). Your complaints have not been evaluated to determine whether the complaint represents an event which is required to be reported to FDA, as required by 21 CFR 820.198(a)(3).
8. Failure to maintain device master records (DMR's) which refer to the location of information such as device specifications, including appropriate drawings, composition, formulation, component specifications, and software specifications, as required by 21 CFR 820.181 (a); production process specifications including appropriate equipment specifications, and production environment specifications, as required by 21 CFR 820.181(b); and quality assurance procedures and specifications with acceptance criteria and equipment to be used, as required by 21 CFR 820.181(c).
9. Failure to establish and maintain procedures to ensure that device history records (DHR's) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part, as required by 21 CFR Part 820.184. You have not established a DHR procedure for your ENDO 150 endoscopic light souce.
10. Failure to maintain a quality system record (QSR) that includes, or refers to the location of; procedures and the documentation of activities, as required by 21 CFR 820.186.
11. Failure to establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed, and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution, as required by 21 CFR 820.160(a).
12. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).
Medical Device Reporting (MDR)
13. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
You 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 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 violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those 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 the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about the content of this letter please contact 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, violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations 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 violations, and take prompt actions to correct the violations and to bring your products into compliance.
Charles M. Breen