FDA import alert

Import Alert 89-08

Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)

1,056

Red-list entries

0

Green-list entries

53

Countries

2026-05-19

Last change seen

Official FDA source ↗Data refreshed 2026-08-27 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
China408
Korea (The Republic Of)105
Canada75
United Kingdom75
Germany50
Hong Kong SAR41
Taiwan34
Italy27
Switzerland25
France21
India21
South Africa15
Japan14
Singapore13
Malaysia9
Turkey9
United States9
Australia8
Israel7
Netherlands7
Sweden7
Czech Republic6
Denmark5
Mexico5
Belgium4

+ 28 more countries

Firms on this red list

Showing 100 of 1,056 entries — search a specific firm on the free checker.

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