FDA import alert
Import Alert 86-11
Detention Without Physical Exam of Contact Lenses Due to Microbiological Contamination
7
Red-list entries
0
Green-list entries
3
Countries
2016-11-29
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 |
|---|---|
| Korea (The Republic Of) | 3 |
| Philippines | 3 |
| Hong Kong SAR | 1 |
Firms on this red list
Showing 7 of 7 entries — search a specific firm on the free checker.
- Aspiration Intl
06/09/2015
Hong Kong SAR · Lens, Contact (Polymethylmethacrylate); Lens, Contact (Other Material) - Daily; Lenses, Soft Contact, Daily Wear
- Con Tech Korea Co. Ltd.
06/16/2014
Korea (The Republic Of) · Lens, Contact (Polymethylmethacrylate); Lens, Contact (Other Material) - Daily; Lenses, Soft Contact, Daily Wear
- Contech Korea
06/16/2014
Korea (The Republic Of) · Lens, Contact (Polymethylmethacrylate); Lens, Contact (Other Material) - Daily; Lenses, Soft Contact, Daily Wear
- MAX LOOK CONTACT LENS / KIM
10/17/2013
Korea (The Republic Of) · Lens, Contact (Polymethylmethacrylate); Lens, Contact (Other Material) - Daily; Lenses, Soft Contact, Daily Wear
- C WORLD KSG CORPORATION
11/19/2015
Philippines · Lenses, Soft Contact, Daily Wear
- RICHARD KIM
11/29/2016
Philippines · Lenses, Soft Contact, Daily Wear
- Richard Kim
11/29/2016
Philippines · Lenses, Soft Contact, Daily Wear
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