FDA import alert
Import Alert 85-02
Detention Without Physical Examination of Condoms
30
Red-list entries
0
Green-list entries
12
Countries
2025-11-18
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.
Red-list entries by country
Firms on this red list
Showing 30 of 30 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
SHANDONG DAHUI LATEX SCIENCE AND TECHNOLOGY CO., LTD
09/26/2011
China · Condom; Condom With Nonoxynol-9; Condom, Non-Latex
Tianjin Medicines & Health Products Import & Export Corp.
09/16/2009
China · Condom
Don Geschenkartikel-Neuheiten Dolores Obidos-Naumann
09/16/2009
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
Suretex, Ltd.
11/18/2025
Thailand · Condom; Condom With Nonoxynol-9; Condom, Non-Latex
PHS Limited
09/16/2009
United Kingdom · Condom
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