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FDA Investigators Tell What They Look For When Inspecting Facilities – But Device Firms Won't Choke If They Adequately Prepare

This article was originally published in The Gray Sheet

Executive Summary

Device manufacturers are being reminded by FDA to make sure that everyone in their organization is familiar with procedures related to agency inspections – but firms will be able to handle that and more if they prepare for audits in advance, industry professional Connie Hoy points out. At device firm Cynosure, "we prepare the entire organization, from the CEO down, for an inspection and what to expect," she says in this Gray Sheet "Compliance Corner" feature.

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