This panel offers an unvarnished “look back” at FSMA implementation from professionals who were engaged from FSMA’s legislative phase through the major rulemakings and into enforcement and implementation across the supply chain. Panelists will examine what worked (e.g., preventive controls and risk-based approaches, stronger documentation expectations), and where implementation has revealed persistent gaps or design limitations. The session will use real-world scenarios to explore issues the law and rules did not fully resolve, including: • Enforcement learnings: What warning letters, inspections, and import actions suggest about FDA expectations versus industry assumptions. • Contract manufacturer oversight: Where the framework creates ambiguity about “who owns” preventive controls, change control, supplier verification, and legal liability when brands outsource manufacturing. • FSVP operational pain points: Including importer identification, role clarity among brokers/agents/consignees, enforcement challenges, and how documentation expectations evolve when corporate structures and logistics models change. • Accountability and practical considerations: Where responsibilities become diffuse across brand owners, co-mans, ingredient suppliers, and importers—and what “good” looks like in practice. The discussion will include what could be included in a “FSMA 2.0” blueprint. This session is designed for FSQA leaders, regulatory counsel, compliance teams, and operations executives seeking both strategic perspective and actionable lessons learned.