Recalls and Detentions: Understanding the Scope of FDA and Related Agencies’ Authority Under FSMA

November 14, 2017 4:30pm

Claudia A. Lewis
Venable LLP (Washington, DC)

  • Exploring FDA’s recall and detention authority under FSMA
  • Tips on how to effectively remove products from the market place once an issue is discovered — making the decision when and how to recall
  • Identifying and correcting regulatory and compliance mishaps that led to the recall
  • Working with state and federal government to streamline the recall process
  • Maintaining proper documentation during a recall in anticipation of litigation that may result from the recall
  • Developing a strategy to address publicity issues that arise as the direct result of a recall