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

Official FDA source ↗Data refreshed 2026-07-11 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.

Red-list entries by country

CountryEntries
Korea (The Republic Of)3
Philippines3
Hong Kong SAR1

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

Does this alert touch your supply chain?

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