Episode notes
In this episode of our advanced cGMP case study series, we take a detailed, practical journey through the FDA’s Investigations Operations Manual—the IOM. Often overlooked outside of regulatory circles, the IOM is in fact the FDA’s own blueprint for how inspections are prepared, conducted, and assessed. We unpack key sections, especially Chapters 5 and 8, revealing how investigators assess risk, structure inspections, and make observations that lead to Form 483s and, potentially, warning letters. With the recent transition from the Office of Regulatory Affairs (ORA) to the new Office of Inspections and Investigations (OII), we also examine how these organizational shifts are amplifying the focus on inspectional rigor. Whether you’re in Quality Assurance, Regulatory Affairs, or site leadership, understanding how the FDA thinks—before, duri ...