An FDA Import Alert tells FDA field personnel that certain products, manufacturers, shippers, countries/regions or other defined categories may be subject to heightened import controls. Many Import Alerts authorize Detention Without Physical Examination (DWPE).
What DWPE means
When an entry falls within the scope of an Import Alert, FDA may detain the affected product without first physically examining or sampling that shipment. The importer then has the burden of addressing the detention and providing evidence supporting admissibility.
Why logistics companies should care
A shipment can be perfectly documented from a transport perspective and still become commercially unusable if the manufacturer/product is subject to DWPE. Checking risk before dispatch can prevent avoidable storage, return, destruction and customer-service costs.
Recommended check
- Search the current FDA Import Alert database using the manufacturer, product and country.
- Read the scope of the specific alert carefully; do not assume every product from a country is affected.
- Check whether the firm or product is specifically listed where the alert contains a Red List or other listing.
- If an alert may apply, obtain regulatory advice before shipping.
Import Alerts change. Always check the current FDA database rather than relying on an old PDF, spreadsheet or prior shipment result.