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 2026-08-28 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.

One-time pilot · $49

Need a dated record for a firm on this alert?

Open any firm below to see its full FDA import alert record for free, then request a source-linked Supplier Evidence Snapshot for your supplier file: red / green status, every matched alert, dates, official FDA links and the dataset timestamp.

Pick a firm on this alertOne-time · no subscription · delivered within one business day after payment

Is your supplier on this alert?

Put your suppliers on watch: we re-check this list (and every other FDA import alert) daily against the official FDA source and email you the day a firm you depend on is added to a red list — or removed from one.

Watch my suppliers — $19/moDaily re-check · email on add / removal · cancel anytime

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.

Does this alert touch your supply chain? Watch your suppliers from $19/mo →

On an import alert? Received a DWPE notice?

Leave your email and we'll connect you with people who handle red-list removals and detentions weekly.