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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Shenberg Dental, dba Therozone 8/11/11

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WL 52-11

August 11, 2011

Dr. James E. Shenberg
President
Shenberg Dental, dba Therozone
2701 Ocean Park Blvd, Suite 108
Santa Monica, California 90405

Dear Dr. Shenberg:

During an inspection of your firm located in Santa Monica, California, on February 24, 2011, through March 16, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures TherO3zone T-1000 and T-8000. 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, their manufacture, packing, storage, or installation are not in conformity 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 your response dated April 6, 2011, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. 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, as required by 21 CFR 820.30(g). For example, your firm has not established procedures for design validation activities for the TherOzone device. Your firm has not documented any design validation activities to demonstrate that the TherOzone T-1000 and T-8000 conform to user needs and intended uses.

The adequacy of your response dated April 6, 2011, cannot be determined at this time. In this response, your firm stated that you will implement design control procedures by April 22, 2011, and promised to perform and document any required retrospective design control activities and develop a design history file by June 10, 2011. Your firm, however, did not provide evidence of implementation of any of these corrective actions.

2. Failure to establish and maintain 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, TherOzone has no agreement with (b)(4) the firm that was hired to do the mechanical package, manufacturing of certain components, assembly, finished product testing, bill of materials, and shipping operations of TherOzone's devices to notify you if there are any changes in these devices or any of the services they provide to you.

The adequacy of your response dated April 6, 2011, cannot be determined at this time. In this response, your firm stated that you will evaluate and classify suppliers, materials, components and purchased assemblies, to establish receiving inspection requirements, and to ensure existing purchasing data is properly maintained by May 13, 2011. Your firm, however, did not provide evidence of implementation of any of these corrective actions.

3. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). For example, your firm has not established procedures for implementing corrective and preventive action.

The adequacy of your response dated April 6, 2011, cannot be determined at this time. In this response, your firm stated that they will conduct a review and investigate nonconformances and implement corrective and preventive action procedures by May 20, 2011. Your firm, however, did not provide evidence of implementation of any of their corrective actions.

4. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm receives complaints, but has not established procedures on how to receive, review, and evaluate complaints by a formally designated unit.

The adequacy of your response dated April 6, 2011, cannot be determined at this time. In this response, your firm stated that you will proceduralize complaint review, and that they will retrospectively review complaints by May 6, 2011. Your firm, however, did not provide evidence of implementation of any of these corrective actions.

5. Failure to establish and maintain procedure to control all documents that are required by the quality system requirements, as required by 21 CFR 820.40. For example, your firm has not established document control procedures.

The adequacy of your response dated April 6, 2011, cannot be determined at this time. In this response, your firm has promised corrective actions referencing the development of a document control system, and maintenance of documents by May 27, 2011. Your firm, however, did not provide evidence of implementation of any of these corrective actions.

6. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system in compliance as required by 21 CFR 820.22. For example, (b)(6) your employee, stated that a quality evaluation of (b)(4) is done twice a year. The quality evaluation performed is not documented.

The adequacy of your response dated April 6, 2011, cannot be determined at this time. In this response, your firm has promised corrective actions referencing the development of a document control system, and maintenance of documents by May 27, 2011. Your firm, however, did not provide evidence of implementation of any of these corrective actions.

7. Failure to establish procedures for management review, as required by 21 CFR 820.20(c). For example, your firm has not implemented management review procedures for evaluating the suitability and effectiveness of the quality system, nor has your firm conducted any management reviews.

The adequacy of your response dated April 6, 2011, cannot be determined at this time. In this response, your firm has promised corrective actions referencing the development of a document control system, and maintenance of documents by May 31, 2011. Your firm, however, did not provide evidence of implementation of any of these corrective actions.

8. 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, your firm has not established a quality policy or objectives.

The adequacy of your response dated April 6, 2011, cannot be determined at this time. In this response, your firm stated that they have established and approved a quality policy and objectives, however, your firm did not provide evidence of implementation of these corrective actions.

Our inspection also revealed that your TherO3zone T -1000 and T -8000 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 devices that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 803 -Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:

Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. Specifically, your firm did not have any written procedures for identifying, communicating, and evaluating events that may be subject to MDR requirements.

We reviewed your response and have concluded that it is not adequate because you stated that your firm will proceduralize the complaint and MDR review criteria and documentation process by May 6, 2011.Your firm, however, did not provide evidence of implementation of any of these corrective actions.

Our inspection also revealed that the TherO3zone T -1000 and T -8000 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. 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your 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) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 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/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

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 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 fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

Finally, your response should be sent to: Mr. Blake Bevill, Director, Compliance Branch, Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612-2506. 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 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 connect the violations and to bring your products into compliance.

Sincerely,

/s/

Alonza E. Cruse
District Director