Understanding FDA Enforcement Tools, Policies, Practices, and Trends

July 27, 2017 3:45pm

Dan Kracov
Arnold & Porter Kaye Scholer LLP (Washington, DC)

Marian Lee
Gibson, Dunn & Crutcher LLP (Washington, DC)

  • Enforcement Overview- Identifying the players and their positions
  • Reviewing FDA Compliance and Enforcement Mechanisms and Best Practices
    • Inspections
    • EIRs
    • Form FDA 483 Observations
    • Untitled and Warning Letters
      • Related to inspections
      • Resulting from non-inspection data or information
    • Imports and Exports
  • Understanding potential punishments including civil seizure, injunction, civil money penalties, and criminal prosecution
  • Current Trends and Key Areas of Focus for CDRH