Inspections, Compliance, Enforcement, and Criminal Investigations
Resonance Technology, Inc. 13-Apr-06
Department of Health and Human Services
Public Health Service
Los Angeles District
Return Receipt Requested
April 13, 2006
Resonance Technology, Inc.
18121 Parthenia Street
Northridge, CA 91325
Dear Mr. Ziarati:
During an inspection of your medical device firm located in Northridge, California, conducted from January 26 to January 27, 2006, our investigator determined that your firm manufactures audio visual systems used by patients undergoing magnetic resonance imaging. These systems are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our inspection disclosed that these devices are adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, and storage are not in conformance with the current Good Manufacturing Practice (GMP) requirements for the Quality System Regulation (QS Regulation), as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
1. Failure of management with executive responsibility to establish a quality policy and objectives for, and commitment to, quality for specific devices manufactured and to ensure that quality policy is understood, implemented and maintained at all levels of the organization, as required by 21 CFR 820.20(a). Specifically, your firm has no written documentation describing the overall intentions and direction of your organization with respect to quality, as established by management with executive responsibility.
2. Failure to establish, maintain and control a quality plan that defines the quality practices, resources, and activities relevant to devices that are designed and manufactured and how the requirements for quality will be met for the specific devices manufactured, as required by 21 CFR 820.20(d). Specifically, your firm has no written documentation that defines the quality practices, resources, and activities relevant to devices that are designed and manufactured.
3. Failure to establish, maintain and control quality system procedures and instructions that meet the requirements of the QS Regulation, as required by 21 CFR §§ 820.5 and 820.20(e). Specifically, your firm has failed to establish quality system procedures to ensure that your quality system meets requirements of the QS Regulation and your established quality policy and objectives.
4. Failure to establish procedures to ensure that management with executive responsibility reviews the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency and document that the quality system requirements are met, as required by 21 CFR 820.20(c). Specifically, your firm does not maintain written management review procedures or document management reviews.
5. Failure to establish and implement procedures for conducting quality audits to assure that the quality system is in compliance with the established quality system requirements, as required by 21 CFR 820.22. Specifically, your firm does not maintain procedures for systematic independent examination of your quality system that is done at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures.
6. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100. Specifically, your firm has no documentation describing the evaluation of potential causes of nonconforming product or other quality problems once they have been identified.
7. Failure to establish, maintain, and control procedures where environmental conditions could reasonably be expected to have and adverse effect on product quality, as required by 21 CFR 820.70(c). Specifically, Electro Static Discharge (ESD) controls have not been established in the electronic assembly area where circuit boards are assembled.
8. Failure to establish and implement procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that all complaints are processed in a uniform and timely manner, as required by 21 CFR 820.198. Specifically, your firm has no established procedures for handling complaints. In addition, your firm has no procedures to determine whether complaints should be reported pursuant to 21 CFR part 803, in violation of 21 CFR 820.198(a)(3).
We acknowledge receipt of your letter dated January 27, 2006, which was submitted in response to the form FDA 483 issued at the conclusion of the inspection. In this response, you stated that you intended to correct the deficiencies noted by FDA within three months. This response was not adequate because you did not submit any supporting documentation or explanations describing how you intend to correct the deficiencies.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA 483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance system. You are responsible for investigating and determining the causes of the violations identified by the FDA.
If the causes are determined to be systems problems, you must promptly initiate permanent corrective actions.
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, no pre-market submissions for devices to which the GMP deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates For Exportability will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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 penalties.
Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. 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.
If you have any questions relating to this letter please contact Senior Compliance Officer, Dannie E. Rowland at 949-608-4448. You may obtain general information about all of FDA's requirements for manufacturers of medical devices through the Internet at http://www.fda.gov.
Please submit your response to:
Pamela B. Schweikert, Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2445
Alonza E. Cruse