Investigator Horror Stories: Industry Insiders Tell Of FDA Inspectional Nightmares – And How Device Firms Handled Them
This article was originally published in The Gray Sheet
In this "Compliance Corner" feature, two industry experts give real-world examples of potential FDA 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.
Register for our free email digests: