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HACCP device inspection concepts' inclusion in quality systems audits to be pursued by FDA.

This article was originally published in The Gray Sheet

Executive Summary

FDA DEVICE INSPECTION POLICY REFLECTING BROADER QUALITY SYSTEMS APPROACH is slated for discussion at a meeting in January between the agency and device industry representatives. The meeting, which is expected to be the first in a series on device inspection policy, will center on manufacturers' desire for FDA to move away from audits focused on complaint files and adverse event reports and to conduct instead a more general review of companies' quality systems.



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