FDA import alert
Import Alert 85-02
Detention Without Physical Examination of Condoms
29
Red-list entries
0
Green-list entries
12
Countries
2024-10-15
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
Firms on this red list
Showing 29 of 29 entries — search a specific firm on the free checker.
- Social Marketing Company
09/16/2009
Bangladesh · Condom; Condom With Nonoxynol-9
- SAGRA LABORATORY
09/16/2009
Chile · Condom; Condom With Nonoxynol-9
- Guilin Zizhu Latex Co., Ltd
09/16/2009
China · Condom; Condom With Nonoxynol-9; Condom, Non-Latex
- Lestitch Co Ltd
08/31/2010
China · Condom; Condom With Nonoxynol-9; Condom, Non-Latex
- Pleasure Chest Group Company Ltd
09/13/2011
China · Condom; Condom With Nonoxynol-9; Condom, Non-Latex
China · Condom; Condom With Nonoxynol-9; Condom, Non-Latex
China · Condom
Germany · Condom
- Anna Mfgr LTD
09/16/2009
Hong Kong SAR · Condom
- Kamlord Co,
10/04/2024
Hong Kong SAR · Condom
- Industat Budapest KFT
09/16/2009
Hungary · Condom
- Cupid Ltd.
10/15/2024
India · Electrocautery, Endoscopic And Accessories; Condom; Condom With Nonoxynol-9
- HEALTH CARE LATEX LTD.
09/16/2009
India · Condom; Condom With Nonoxynol-9
- Hindustan Latex, Limited
09/16/2009
India · Condom
- M/S Suruchi International
09/16/2009
India · Condom; Condom With Nonoxynol-9; Condom, Non-Latex
- Hatu-Ico S.P.A.
10/01/2024
Italy · Condom
- Blueberry NFT Co., Ltd
03/24/2016
Korea (The Republic Of) · Condom; Condom With Nonoxynol-9; Condom, Non-Latex
- Greenmate Corporation
09/16/2009
Korea (The Republic Of) · Condom
- Hyosung Corp.
10/04/2024
Korea (The Republic Of) · Condom
- Orient Medical Supply Co Ltd (office)
09/16/2009
Korea (The Republic Of) · Condom
- Orient Medical Supply Co., Ltd.
09/16/2009
Korea (The Republic Of) · Condom
- Shinheng Corporation
09/16/2009
Korea (The Republic Of) · Condom
- Sol Medical Supply Co. Ltd.
09/16/2009
Korea (The Republic Of) · Condom
- Unidus Corporation
03/24/2016
Korea (The Republic Of) · Condom; Condom With Nonoxynol-9; Condom, Non-Latex
- Asbien Sdn Bhd
10/01/2024
Malaysia · Condom
- LS Rubber Sdn. Bhd.
09/16/2009
Malaysia · Condom
- Royal Industries Thailand Co Ltd
09/16/2009
Thailand · Condom
- S L D International Co Ltd aka Ken Nona
09/16/2009
Thailand · Condom
- PHS Limited
09/16/2009
United Kingdom · Condom
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