Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Los Angeles District
VIA UNITED PARCEL SERVICE
October 25, 2012
William C. Domb, DMD
A Professional Corporation
190 N. Mountain Avenue
Upland, California 91786
Dear Dr. Domb:
During an inspection of your firm located in Upland, California, on February 16, 2012, through March 20, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Ozone Generating System devices. Additionally, an investigator from the FDA attended your course, entitled, “US Pathfinders Intro-Basic Ozone Course” held on July 6-7, 2012 at your facility at 190 N. Mountain Avenue, Upland, California. Our investigator observed that you continue to be a manufacturer of medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 32l(h), because the products that you make 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.
Our inspections revealed that the Ozone Generating System devices are adulterated under section 501(f)(l)(B) of the Act, 21 U.S.C. § 351(f)(l)(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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) 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, 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) 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/HowtooMarketYourDevice/default.htm. The FDA will evaluate. the information that your firm submits and decide whether the product may be legally ·marketed.
Our February-to-March 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, 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 a response dated March 20, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which 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 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. For example, when asked by the investigator, staff at your firm replied that your firm does not have any design control procedures and has not established any of the design controls activities.
2. Failure to establish and maintain procedures for validating the device design to include risk analysis, as required by 21 CFR 820.30(g). For example, when asked by the investigator, staff at your firm replied that no risk analysis was performed by your firm to ensure that ozone levels do not exceed the acceptable level of ozone (under 0.05 parts per million), as referenced in 21 CPR 801.415(c)(1).
3. Failure to establish and maintain procedures for corrective and preventive action, as required by 21 CFR 820.100(a). For example, when asked by the investigator, staff at your firm replied that your firm has not established any procedures for corrective and preventive action.
4. 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, when asked by the investigator, staff at your firm replied that your firm has no purchasing control procedures and no procedures to address the evaluation of suppliers and describe specified quality requirements for components.
5. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm has received complaints; however, when asked by the investigator, staff at your firm replied that your firm has not established complaint handling procedures that address the uniform and timely processing of complaints, documentation of oral complaints, or the evaluation of complaints required to be reported to FDA as Medical Device Reports.
6. Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a). For example, when asked by the investigator, staff at your firm replied that your firm has not implemented procedures, and does not document that device components and in process and finished devices conform to specified requirements.
7. Failure of management with executive responsibility to establish its policy and objectives for, and commitment to, quality, as required by 21 CFR 820.20(a). For example, when asked by the investigator, staff at your firm replied that your firm has not defined, documented, and implemented a quality policy and quality objectives.
8. Failure to establish procedures for management review, as required by 21 CFR 820.20(c). For example, when asked by the investigator, staff at your firm replied that your firm has not conducted management reviews and it has no established procedure.
9. Failure to establish procedures for quality audits and to 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. For example, when asked by the investigator, staff at your firm replied that your firm has not conducted any quality audits to evaluate the suitability and effectiveness of the quality system.
10. Failure to prepare and maintain device master records, as required by 21 CFR 820.181. For example, when asked by the investigator, staff at your firm replied that specifications for the various components of the device were not identified; process procedures providing instruction to customers on assembly were not identified; quality assurance procedures and acceptance criteria were not identified; and labeling specifications for manuals provided with the Ozone Generating System devices for personal distribution were not identified.
11. Failure to adequately maintain device history records, as required by 21 CFR 820.184. For example, when asked by the investigator, staff at your firm replied that complete device history records are not prepared and maintained for the Ozone Generating System devices. Approximately (b)(4) Ozone Generating System devices have been sold and distributed over the last (b)(4) .
Your response dated March 20, 2012 is not adequate. Your firm does not specifically address any of the above observations. The response does not include a description and evidence of implementation of corrections, corrective actions, and systemic corrective actions. Your firm only notes that it will immediately change its protocols and processes with no specific dates for doing so.
Our inspection also revealed that your firm’s Ozone Generating System 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 written Medical Device Reporting (MDR) procedures, as required by 21 CPR 803.17. For example, your film failed to develop, maintain, and implement written MDR procedures for identifying, communicating, and evaluating events that may be subject to MDR requirements.
We reviewed your firm’s response and conclude that it is not adequate. Your firm does not specifically address this observation. The response does not include a description and evidence of implementation of corrections, corrective actions, and systemic corrective actions. Your firm only notes that it will immediately change its protocol and processes with no specific dates for doing so. Under section 510 of the Act, 21 U.S.C. § 360, manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2012.
Therefore all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the devices were manufactured, prepared propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360, and were not included in a list required by section 510(j) of the Act, 21 U.S. C.§ 360(j).
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 (including any systemic corrective actions) 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: Mr. Blake Bevill, Compliance Branch, Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612-2506. Refer to the Unique Identification Number CMS case # 295318 when replying. If you have any questions about the content of this letter please contact: Dr. William Vitale at 949-608-2919.
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.
Alonza E. Cruse, Director
Los Angeles District
cc: Ms. Ingeborg Small, Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS 7602
P.O. Box 997435
Sacramento, CA 95899-7435
This page was posted on September 8, 2015.