FDA import alert
Import Alert 41-03
Detention Without Physical Examination of Adulterated and Misbranded Medical Foods
2
Red-list entries
0
Green-list entries
2
Countries
2014-04-18
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.
Red-list entries by country
| Country | Entries |
|---|---|
| Mexico | 1 |
| South Africa | 1 |
Firms on this red list
Showing 2 of 2 entries — search a specific firm on the free checker.
RUBIO DE B.C., S.A. DE C.V.
04/18/2014
Mexico · Oral Rehydration Products
Sunspray Food Ingredients (Pty) Ltd
11/22/2010
South Africa · Medical Foods (Formulated for disease treatment); Dietary Conventional Foods, N.E.C.
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