FDA import alert
Import Alert 57-11
DETENTION WITHOUT PHYSICAL EXAMINATION OF UNLICENSED IMMUNE GLOBULIN INTRAVENOUS (HUMAN)
2
Red-list entries
0
Green-list entries
1
Countries
2009-09-10
Last change seen
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
| Country | Entries |
|---|---|
| United Kingdom | 2 |
Firms on this red list
Showing 2 of 2 entries — search a specific firm on the free checker.
- A.D. Allen Pharmaceutical Wholesaler
09/10/2009
United Kingdom · Immune Globulin Intravenous, Final Product; Ready For Use
- B & S Durbin Ltd
09/10/2009
United Kingdom · Immune Globulin Intravenous, Final Product; Ready For Use
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