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Investigator Horror Stories: Industry Insiders Tell Of US FDA Inspectional Nightmares - And How Device Firms Handled Them

This article was originally published in SRA

Executive Summary

Two industry experts give real-world examples of potential US Food and Drug Administration's inspectional overreaches, including one investigator who followed a device firm's employee into a restroom to stop her from using a cell phone. Yes, that actually happened - and it's just one of many inspectional nightmares that manufacturers have faced when inspected by the agency.

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