Thursday, March 29, 2012

Avoiding and Responding to FDA Import Alerts

is being presented by Lisa Capote, Partner, with Arrastia & Capote LLP and airs on Tuesday, April 3rd, 2012. For more details, or to register please visit our site at www.fxconferences.com

When companies, products or geographical regions are added to import alerts, also known as detention without physical examination, you can rest assured you are not getting through the US border without some additional effort on your part. At the point in time one of your products is listed on an import alert the product is automatically detained by FDA with assistance of Customs and Border Protection and it is your obligation to convince FDA that your product complies with the regulations. If the evidence you provide FDA is insufficient to merit release, the product will be refused entry. The process of having the product detained while you plead with FDA for a release can result in increased costs to the importer.

This audio conference presentation provides detail on FDA’s import alert process, and looks at the factors that result in facilities or their products being placed on import alert. Our speaker shares insight on proactive steps you can take to avoid this “blacklist” as well as some best practices to follow to be removed from import alert.