Recalls and Detentions: Understanding the Scope of FDA and Related Agencies’ Authority
Miriam Guggenheim
Partner
Covington & Burling LLP
Daniel Dwyer
Partner
Kleinfeld Kaplan & Becker LLP
- Exploring FDA’s recall and detention authority and how this changed under FSMA
- Tips on how to effectively remove products from the marketplace 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 a direct result of a recall