FDA import alert

Import Alert 89-17

Detention Without Physical Examination of Medical Devices That Appear to Be Adulterated Because Their Quality Falls Below That Which They Purport or Are Represented to Possess

13

Red-list entries

0

Green-list entries

4

Countries

2026-04-01

Last change seen

Official FDA source ↗Data refreshed 2026-10-24 UTC

What being on this list means

Firms on an import alert's Red List are subject to Detention Without Physical Examination (DWPE): FDA can detain their shipments at the border automatically, without sampling or inspecting them. The burden shifts to the importer to prove — typically with private laboratory analysis, shipment by shipment — that the goods are not violative. Removal from the list requires evidence that the underlying problem is resolved, usually including a track record of consecutive clean shipments and a petition to FDA. How removal works →

A Green List on a countrywide alert works the other way: it names the firms FDA has excluded from detention because they demonstrated compliance.

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Red-list entries by country

CountryEntries
China7
Pakistan3
Mexico2
Canada1

Firms on this red list

Showing 13 of 13 entries — search a specific firm on the free checker.

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