FDA 483s, Warning Letters & Enforcement Trends – Webinar Recording/Transcript

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FDA 483s, Warning Letters & Enforcement Trends

Want to attend the live webinar on Nov. 25?  Click here to register.

How should you prepare for your next inspection?

The answer, hiding in plain sight, lies in the analysis of recent FDA enforcement trends. And who better to guide you than top Washington FDA lawyers Chalana Damron Esq. and John Fuson Esq. of Crowell & Moring LLP.

Join them for a 90-minute tour of current FDA enforcement trends. This webinar helps you shape your policies and practices with an eye on keeping the agency at bay.

Presentation Takeaways

  • Enforcement trends: 2019 FDA enforcement activity — 483s and warning letters — vs. prior years
  • Most prevalent targets of FDA inspections
  • GMP violations most often cited in 483s and in warning letters
  • Managing inspections to minimize risk of escalation
  • How lawsuits are born: The role that FDA enforcement actions play

Strengthen your quality and compliance systems based on proven trends.

  • Compliance Management
  • Regulatory and Compliance Affairs Personnel
  • API Providers
  • Manufacturing Professionals
  • Laboratory Professionals
  • Quality Professionals
Meet Your Presenters

John Fuson
Partner in the Health Care, Product Risk Management (PRM), and White Collar and Regulatory Enforcement groups at Crowell & Moring, LLP
John Fuson Esq. served as associate chief counsel of the FDA prior to joining Crowell & Moring. He had broad law enforcement responsibilities, handling major enforcement actions brought by the agency, including seizure actions, injunction actions, actions for civil money penalties, and contempt actions. His cases involved drugs, devices, food, and veterinary drugs. Now he shares his insider view with you.

Chalana N. Damron
Counsel in the Mass Tort, Product, and Consumer Litigation Group at Crowell & Moring, LLP
Chalana N. Damron Esq. helps clients make ready for FDA inspections, evaluate quality systems and respond to 483 observations. She regularly evaluates and comments on litigation and regulatory developments affecting FDA-regulated firms and helps clients limit marketing-related challenges from lawsuits and regulators.