Complaint handling procedures cited at Amrex Zetron.(Medical Devices)

April 14--Los Angeles District

An Oct. 21-Nov. 3 inspection of Amrex Zetron, based in Carson, CA, revealed the company did not have a PMA or IDE for any of its neurological electrotherapy products.

The company did not have adequate complaint handling procedures, the agency wrote. Neither its "Customer-Related Processes. nor "Corrective Action and Preventive Action. procedures included adequate procedures for complaint handling.

Amerx Zetron did not adequately conduct an investigation nor maintain a record of the investigation by the formally designated unit. With respect to a customer complaint, the device identification and control number used were not recorded; in another instance of a customer complaint, the results of testing of the returned devices were not included.

The company did not submit documentation of implementation of the correction to this observation, so its response was inadequate, FDA found.

The company did not establish and document procedures to ensure that all inspection, measuring and test equipment was suitable for its intended purposes and capable of producing valid results. The equipment used for finished device release testing, the Oscilloscope SS-6122 and the Ultrasound Power Meter, were out of calibration and the firm did not have established procedures to document and ensure equipment calibration procedures.

Amrex Zetron's response did not include documentation with a description and evidence of implementation of the correction, FDA stated in declaring the response inadequate. "Your firm has proposed preventive action but has not implemented that plan," the agency wrote.

The same was true of the company's proposed action regarding its failure to establish and maintain instructions and procedures for performing and verifying servicing procedures; to analyze service reports with appropriate statistical methodology; or 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. In the last case, Amrex Zetron said it would develop a schedule for quality audits.

The firm had not conducted a Management Review in the past six years, the most recent being documented in 2002, FDA stated. Again, the response was not adequate because no documentation was submitted to prove Amrex Zetron had implemented the correction.

The company had no approved, released or implemented Quality Manual and was not able to produce any other documented quality procedures, the warning letter noted. Management with executive responsibility failed to establish and maintain quality policy; the company's quality policy dated May 11, 2004, had not been approved or released. The company also failed to ensure that the quality policy was understood and fully implemented and maintained at all levels of the organization. Six of nine employees' training records showed they had not been trained on the Quality Policy.

FDA also deemed Amrex Zetron's devices misbranded, due to its failure to establish, maintain and implement written Medical Device Reporting (MDR) procedures. The company replied that it would correct the deviation by revising the quality manual to include a procedure for MDR. However, FDA wrote, "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." CAPA; C-H; Cal; MDR; PMA; QC/QS

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