Understanding FDA Enforcement Tools, Policies, Practices, and Trends

July 21, 2016 8:45am

What is it about?

  • Enforcement Overview – What FDA Can Do & Players Beyond FDA
  • FDA Compliance & Enforcement Mechanisms & Best Practices
    • Inspections
    • EIRs
    • Form FDA 483 Observations
    • Untitled & Warning Letters
      • Inspection-related
      • Based on other data & information
    • Imports & Exports
    • Civil Seizure
    • Injunction
    • Civil Money Penalties
    • Criminal Prosecution
  • Current Key Areas of Focus for CDRH
  • Enforcement Trends: FDA, Park Doctrine, DOJ & OIG

Session Materials