FDA Warning Letters Tracker


This tracker is intended as a tool to assist attorneys representing drug and medical device companies who need to monitor trends in Food and Drug Administration (FDA) enforcement activity affecting their clients. This tracker highlights selected drug and medical device-focused warning letters issued by the FDA in response to FDA’s determination that a manufacturer has violated, or potentially violated, applicable requirements of the Food, Drug, and Cosmetics Act (FDCA), FDA regulations, or agency guidance. It also highlights warning letters for products related to coronavirus disease (COVID-19).