FDA import alert

Import Alert 89-18

Detention Without Physical Examination of Filtering Facepiece Respirators (FFR)

33

Red-list entries

0

Green-list entries

1

Countries

2021-06-22

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
China33

Firms on this red list

Showing 33 of 33 entries — search a specific firm on the free checker.

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