What is FDA automatic detention lists?

USFDA Import Alerts, also called FDA automatic detention lists, are used by FDA to provide notice to its District Offices and FDA import inspection and compliance officers that a foreign manufacturer and its products appear to be in violation of the Food Drug and Cosmetic Act (FDCA) or FDA regulations.

In most circumstances, firms and products that are listed on an FDA Import Alert are automatically detained by FDA without the added step of FDA conducting an inspection, examination or sampling of the product. FDA automatically detains products on FDA Import Alert without physical examination (also called Detention Without Physical Examination or DWPE).

DWPE – DETENTION WITHOUT PHYSICAL EXAMINATION

Firms listed on an FDA Import Alert will find it harder to compete in the U.S. marketplace. The FDA publishes its Import Alerts on the Internet, so competitors and potential customers are able to see that a firm has been added to an FDA Import Alert and its products are subject to automatic detention (or DWPE). It is very important for manufacturers or shippers listed on an FDA import alert to get off of the alert as soon as possible.

There are different types of FDA Import Alerts, including those Import Alerts that identify a specific manufacturer, shipper, grower, and product combination. Some Import Alerts list specific geographic areas that have presented problems for FDA.