FDA Inspections: Where We Are and Where We’re Headed (RAPS Webcast)

An inspection by the US Food and Drug Administration (FDA) is the price every regulated company pays to conduct business in the US. As a critical part of the current FDA enforcement environment, vigorous domestic inspections continue and foreign inspections, with the addition of posts in certain geographic regions, have increased. A poor inspection can result in enforcement actions, which cause substantial business disruption or adverse commercial relationships with customers, investors or potential partners. Similarly, failure to obtain satisfactory inspection outcomes can lead to product approval delays or shipment detentions into the US, which can have significant economic consequences.

This webcast will provide an overview of FDA’s inspectional authority, the agency’s enforcement tools, and insight into where FDA inspection practices are headed. It will also offer recommendations to minimize enforcement risk and business disruptions, as well as how best to prepare a response and game plan if things take a turn for the worse.