Dealing with FDA and Their Inspection Enforcement Tools - Webinar Recording/Transcript

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Dealing with FDA and Their Inspection Enforcement Tools

Successfully navigating inspections is essential to your relationship and reputation with the FDA. And, of course, it’s key to securing approval for your product and getting it to market.

Make the most of your next inspection with insights from a former Associate Chief Counsel for Enforcement at the FDA. 

Presentation Takeaways:

  • Best practices for answering FDA Form 483 observations
  • Strategies for avoiding warning letters and serious enforcement actions
  • Tips for building agency confidence in site operations
  • Tools for assessing company exposure to regulatory risk — including identifying hot-button issues for inspections
  • Knowledge of FDA factors that renders enforcement or escalations

Avoid escalation to injunctions by knowing how to respond to FDA enforcement actions.

  • Executive Management
  • Regulatory Affairs
  • Quality Assurance/Quality Control
  • Legal and Compliance Officers
  • Consultants/Service Providers

John Fuson, Partner, Crowell & Moring, LLP; former Associate Chief Counsel for Enforcement at FDA
John Fuson is a partner in the firm's Health Care, Product Risk Management (PRM), and White Collar and Regulatory Enforcement groups, focusing on FDA enforcement and counseling matters. Before joining Crowell & Moring, John served as associate chief counsel at the FDA, with broad law enforcement responsibilities. While at the FDA, John handled all types of major enforcement actions brought by the agency, including seizure actions, injunction actions, actions for civil money penalties, and contempt actions.