Recalls and Detentions: Understanding the Scope of FDA and Related Agencies’ Authority Under FSMA
Claudia A. Lewis
Partner
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
