FDA import alert

Import Alert 99-34

DETENTION WITHOUT PHYSICAL EXAMINATION OF DRUGS OR MEDICAL DEVICES FROM FIRMS WITHOUT A VALID DRUG OR MEDICAL DEVICE REGISTRATION AND/OR LISTING

70

Red-list entries

0

Green-list entries

19

Countries

2026-10-13

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
China18
Korea (The Republic Of)9
United Kingdom6
India5
Germany4
Vietnam4
France3
Hong Kong SAR3
Netherlands3
Poland3
Malaysia2
Sweden2
United States2
Greece1
Hungary1
Italy1
Spain1
Taiwan1
United Arab Emirates1

Firms on this red list

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