FDA import alert

Import Alert 86-07

Detention Without Physical Examination Of Impact-Resistant Lenses In Eyeglasses And Sunglasses

28

Red-list entries

0

Green-list entries

3

Countries

2022-03-02

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
China22
Taiwan5
United States1

Firms on this red list

Showing 28 of 28 entries — search a specific firm on the free checker.

  • COOMEX SOURCE LIMITED

    08/26/2010

    China · Gauge, Lens, Ophthalmic; Lens, Spectacle, Non-Custom (Prescription); Sunglasses (Non-Prescription Including Photosensitive)

  • DANYANG SAN-SINO OPTICAL CO., LTD.

    08/26/2010

    China · Gauge, Lens, Ophthalmic; Lens, Spectacle, Non-Custom (Prescription); Sunglasses (Non-Prescription Including Photosensitive)

  • Glory International Trading Inc

    06/27/2011

    China · Spectacle, Magnifying; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear); Sunglasses (Non-Prescription Including Photosensitive)

  • Guangzhou Universal Optical Products Co., Ltd.

    12/20/2011

    China · Spectacle, Magnifying; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear); Sunglasses (Non-Prescription Including Photosensitive)

  • JIANGXI LOOK OPTICAL INDUSTRIAL CO., LTD.

    04/20/2015

    China · Sunglasses (Non-Prescription Including Photosensitive)

  • LINHAI CITY ZHENXIAN GLASSES FACTORY

    02/02/2015

    China · Specula, Ophthalmic; Spectacle, Magnifying; Lens, Spectacle, Non-Custom (Prescription)

  • Linhai Botao Glasses Co Ltd

    11/29/2013

    China · Lens, Spectacle, Non-Custom (Prescription); Sunglasses (Non-Prescription Including Photosensitive)

  • Linhai City Qianbaidu Glasses Factory

    07/19/2012

    China · Lens, Spectacle, Non-Custom (Prescription); Sunglasses (Non-Prescription Including Photosensitive)

  • Linhai Industrial Glasses Factory

    10/11/2013

    China · Sunglasses (Non-Prescription Including Photosensitive)

  • Linhai Xuanhong Glasses Factory

    08/28/2017

    China · Lens, Spectacle, Non-Custom (Prescription); Sunglasses (Non-Prescription Including Photosensitive)

  • MEIAOQI

    03/08/2017

    China · Sunglasses (Non-Prescription Including Photosensitive)

  • San Ho Hasts

    02/02/2015

    China · Sunglasses (Non-Prescription Including Photosensitive)

  • See-Good Enterprise Co., Ltd

    01/23/2014

    China · Sunglasses (Non-Prescription Including Photosensitive)

  • Sunfree Enterprise Co Ltd

    05/03/2011

    China · Spectacle, Magnifying; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear); Sunglasses (Non-Prescription Including Photosensitive)

  • TAIZHOU PINXIN GLASSES CO., LTD

    05/04/2018

    China · Sunglasses (Non-Prescription Including Photosensitive); Frame, Spectacle

  • TAIZHOU WEIFENG GLASSES CO., LTD.

    10/31/2011

    China · Spectacle, Magnifying; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear); Sunglasses (Non-Prescription Including Photosensitive)

  • Taizhou Hongfa Glasses Co., Ltd.

    07/01/2016

    China · Specula, Ophthalmic; Spectacle, Magnifying; Lens, Spectacle, Non-Custom (Prescription)

  • Tazhou Meidiya Glasses Co., Ltd.

    06/24/2014

    China · Specula, Ophthalmic; Spectacle, Magnifying; Lens, Spectacle, Non-Custom (Prescription)

  • Tzong Rong Optical Co., Ltd.

    05/03/2011

    China · Spectacle, Magnifying; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear); Sunglasses (Non-Prescription Including Photosensitive)

  • Wenzhou N & A Foreign Trade Corp.

    03/11/2015

    China · Specula, Ophthalmic; Spectacle, Magnifying; Lens, Spectacle, Non-Custom (Prescription)

  • Wenzhou Ouhua Foreign Trade Corp.

    09/22/2010

    China · Gauge, Lens, Ophthalmic; Lens, Spectacle, Non-Custom (Prescription); Sunglasses (Non-Prescription Including Photosensitive)

  • Yh Optics Int Ltd

    10/23/2012

    China · Spectacle, Magnifying; Lens, Spectacle, Non-Custom (Prescription); Sunglasses (Non-Prescription Including Photosensitive)

  • Co-World Technology Co. Ltd.

    05/28/2014

    Taiwan · Specula, Ophthalmic; Spectacle, Magnifying; Lens, Spectacle, Non-Custom (Prescription)

  • Dots Eyewear Inc.

    07/07/2016

    Taiwan · Sunglasses (Non-Prescription Including Photosensitive)

  • Hang Chow Industrial Co Ltd

    07/15/2010

    Taiwan · Gauge, Lens, Ophthalmic; Lens, Spectacle, Non-Custom (Prescription); Sunglasses (Non-Prescription Including Photosensitive)

  • Koadak Optical Ind Co.,Ltd

    04/20/2015

    Taiwan · Sunglasses (Non-Prescription Including Photosensitive)

  • NEW ERA ENTERPRISE CO.,LTD.

    10/13/2021

    Taiwan · Sunglasses (Non-Prescription Including Photosensitive)

  • Glory International Trading Inc

    03/02/2022

    United States · Spectacle, Magnifying; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear); Sunglasses (Non-Prescription Including Photosensitive)

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