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.