FDA import alert

Import Alert 89-04

Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System Requirements

176

Red-list entries

0

Green-list entries

30

Countries

2026-07-02

Last change seen

Official FDA source ↗Data refreshed 2026-10-15 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
China37
Canada18
United Kingdom14
Germany9
Korea (The Republic Of)9
Taiwan9
France8
Italy8
Japan7
Malaysia6
Netherlands5
Pakistan5
Australia4
Mexico4
Spain4
Switzerland4
Thailand4
Argentina3
India3
Indonesia3
Hong Kong SAR2
Ireland2
Belgium1
Brazil1
Bulgaria1

+ 5 more countries

Firms on this red list

Showing 100 of 176 entries — search a specific firm on the free checker.

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