Understand the sources and scope of FDA’s enforcement authorities. Explore FDA’s administrative enforcement tools (including inspections, 483s, and Warning Letters) and the circumstances in which FDA uses them. Highlight and examine FDA’s authority to seek civil injunctions, seize violative products from the market, and conduct criminal investigations into problematic activity.
Peter J. Leininger, Partner, King & Spalding LLP
This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in November 2022.