A Breakdown of the FDA Announcement of Unannounced Foreign-Based Inspections from the Quantitative Perspective: Poster Presented at PDA Week 2026.

In response to the FDA's recent policy shift towards conducting unannounced foreign inspections, the global pharmaceutical industry faces new challenges in maintaining a constant state of readiness. This data-driven presentation moves beyond speculation and provides a quantitative analysis of this critical change. Using publicly available data from the FDA's inspection records and data dashboards, we will present a case study analyzing the initial impacts of this policy.