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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Amrex-Zetron, Inc. 4/14/09

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

April 14, 2009

W/L 16-09

Mr. George L. Bell
President/CEO
Amrex-Zetron, Inc.
641 East Walnut Street
Carson, CA 90746

Dear Mr. Bell:

During an inspection of your firm located in Carson, California on October 21 through November 3, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the following neurological electrotherapy products: Z- Stim IF250 Interferential/Russian Stimulator; MS324C Low Volt AC Muscle Stimulator; MS401B Bi Phasic/Mono Phasic Stimulator; CB95 IF250 Interferential and U/50 Ultrasound Combination; Combination Ultrasound/High Volt Stimulator -SynchroSonic US/752; Combination Ultrasound/Low Volt Galvanic/High Volt Stimulator- SynchroSonic U/HVG50; SynchroSonic U/50 and U/20 Portable Ultrasound; Low Voltage Galvanic for Iontophoresis and Galvanic Therapy - LVG325A; Low Voltage AC Muscle Stimulator - MS324A, MS324AB, MS322; Combination Ultrasound/Low Volt AC Stimulator - SynchroSonic US/54 and US/50; Dual Channel T.E.N.S. - AdvanTeq 2000; Microcurrent Generator -SpectrumMICRO - 1000; High Volt Pulsed DC Stimulator -SyncroPulse HV752; and the Z-Stim IF 150 Interferential/Stimulator. 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.

Our inspection revealed that these 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 per 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.

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, 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 a response from Mr. Jeff Maddy, Operations Support dated November 17, 2008, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. Where appropriate, we address this response below, individually or collectively, in relation to each of the noted violations . These violations include, but are not limited to, the following:

1. Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198. For example, you do not have adequate complaint handling procedures. Neither your "Customer-Related Processes" nor your "Corrective Action and Preventive Action" procedures include adequate procedures for complaint handling.

2. Failure to adequately conduct an investigation and to maintain a record of the investigation by the formally designated unit, as required by 21 CFR 820.198. For example, with respect to customer complaint (b)(4) the device identification and control number(s) used were not recorded, and with respect to customer complaint (b)(4) the results of testing of the returned devices were not included.

Your firm's response dated November 17, 2009, is not adequate because you have not submitted documentation of implementation of the correction. Your firm has proposed to update the database records with the results of complaint investigations.

3. Failure to establish and document procedures 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). For example, the equipment used for finished device release testing, i.e., the Oscilloscope SS-6122 (calibration due May 18, 2008) and the Ultrasound Power Meter UPM-DT-10 (calibration due June 15, 2008) were out of calibration and your firm does not have established procedures to document and ensure equipment calibration procedures.

Your firm's response dated November 17, 2009, is not adequate because you have not submitted documentation which includes a description and evidence of implementation of the correction. Your firm has proposed preventive action but has not implemented that plan.

4. Failure to establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements, as required by 21 CFR 820.200(a). For example, your firm has not established any servicing procedures. Your firm's response dated November 17, 2009, is not adequate because your firm has not submitted documentation of implementation of the correction. Your firm has proposed preventive action but has not implemented that plan.

5. Failure to analyze service reports with appropriate statistical methodology in accordance with 21 CFR 820.100, as required by 21 CFR 820.200(b). For example, your firm does not perform service report analysis.

Your firm's response dated November 17, 2009, is not adequate because your firm has not submitted documentation of implementation of the correction. Your firm has proposed preventive action but has not implemented that plan.

6. Failure to adequately establish and maintain procedures for conducting quality 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, according to your Operations Support management, your firm's last documented internal quality audit was conducted in 2002.

Your firm's response dated November 17, 2009, is not adequate because your firm has not submitted documentation of implementation of the correction. Your firm has proposed that a schedule for quality audits would be developed.

7. Management with executive responsibility failed to adequately establish and maintain management review procedures to ensure the review, conduct and document the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency, as required by 21 CFR 820.20(c). For example, your firm has not conducted a Management Review in the past 6 years, the most recent being documented in 2002.

Your firm's response dated November 17, 2009, is not adequate because your firm has not submitted documentation of implementation of the correction. Your firm has proposed preventive action but has not implemented that plan.

8. Failure to establish and implement quality system procedures, as required by 21 CFR 820.20(e). For example, your Quality Manual has not been approved, released or implemented. Your firm was not able to produce any other documented quality procedures.

Your firm's response dated November 17, 2009, is not adequate because your firm has not submitted documentation of implementation of the correction, and the corrective action. Your firm has proposed preventive action.

9. Management with executive responsibility failed to establish and maintain its quality policy and objectives for, and commitment to, quality and failed to ensure that its quality policy is understood and fully implemented and maintained at all levels of the organization, as required by 21 CFR 820.20(a).

For example:

a. Your quality policy, Amrex-Zetron, Inc., ISO 13485 Quality Manual, Revision 1, Date: May 11, 2004, has not been approved or released.

b. Six of nine employees training records show employees have not been trained on the Quality Policy.

Your firm's response dated November 17, 2009, is not adequate because your firm has not submitted documentation of implementation of the correction. Your firm has proposed preventive action but has not implemented that plan.

Our inspection also revealed that your 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 C.F.R. Part 803 Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:

Failure to establish, maintain and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, your firm has not established written MDR procedures.

We have reviewed your response and have concluded that it is inadequate because the response states that the deviation will be corrected by revising the quality manual to include a procedure for MDR. The response does not contain the revised procedures nor does it explain the nature of the change to be implemented or explain how and/or why the change adequately addresses this deviation. The response also lacks evidence showing that the change has been implemented, including evidence of training appropriate personnel on the change. Please provide this information for our review.

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:

E. Mark Harris
Acting 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. Raymond W. Brullo, Compliance Officer at 949.608.2918.

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.

 

Sincerely yours,

/s/
 

Alonza E . Cruse
District Director

Cc: Jeff Farrar, DVM, PhD, MPH
Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413