FDA import alert
Import Alert 89-16
Detention Without Physical Examination of Products from Medical Device Firms Refusing FDA Foreign Establishment Inspection
6
Red-list entries
0
Green-list entries
4
Countries
2023-12-11
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 |
|---|---|
| China | 3 |
| India | 1 |
| Korea (The Republic Of) | 1 |
| Taiwan | 1 |
Firms on this red list
Showing 6 of 6 entries — search a specific firm on the free checker.
- Intop Tech Co Ltd 2005 Dragon Bearl
05/22/2013
China · Anesthesiology; Cardiovascular; Dental
China · Anesthesiology; Cardiovascular; Dental
China · Anesthesiology; Cardiovascular; Dental
- Sewa Medicals Ltd
05/28/2014
India · Anesthesiology; Cardiovascular; Dental
- Dongkuk Trading Company, Ltd.
03/15/2021
Korea (The Republic Of) · Anesthesiology; Cardiovascular; Dental
- Morris Engineering Works Ltd.
09/16/2014
Taiwan · Anesthesiology; Cardiovascular; Dental
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