FDA Tracker by Leucine is an AI-powered platform that helps pharmaceutical and life sciences companies stay ahead of regulatory risks. With real-time insights into FDA inspection trends, 483 observations, and warning letters, FDA Tracker empowers teams to benchmark performance, uncover hidden risks, and proactively close compliance gaps—before the regulator comes knocking. Key Features Real-Time Inspection Data: Access the latest FDA inspections, 483s, and warning letters across facilities and regions. Company & Site-Level Insights: Drill down into specific companies or sites to benchmark against industry peers. AI-Powered Risk Signals: Spot emerging compliance risks and common failure patterns using smart analytics. Search & Filter with Precision: Find exactly what you need—by product type, region, observation code, and more. Compliance Heatmaps & Dashboards: Visualize performance trends and identify red flags in seconds. Exportable Reports: Create shareable reports for internal audits, board reviews, or inspection readiness plans. Business Impact Proactively Close Compliance Gaps with early visibility into regulatory trends Benchmark Performance against industry peers and FDA expectations Enhance Audit Readiness by focusing on real-world inspection patterns Drive Smarter Quality Decisions with data-backed risk intelligence