FDA import alert
Import Alert 79-01
Detention Without Physical Examination of Topical/External Bandages, Dressings, Gauzes/Sponges and Cotton Pads Due to Microbiological Contamination
28
Red-list entries
0
Green-list entries
9
Countries
2019-06-04
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
| Country | Entries |
|---|---|
| China | 18 |
| Canada | 2 |
| Mexico | 2 |
| Germany | 1 |
| Hong Kong SAR | 1 |
| India | 1 |
| Japan | 1 |
| Korea (The Republic Of) | 1 |
| Pakistan | 1 |
Firms on this red list
Showing 28 of 28 entries — search a specific firm on the free checker.
Executive Promotions
09/16/2009
Canada · Dressing, Wound, Drug; Tape And Bandage, Adhesive; Kit, First Aid
Shanmark Medical Products Inc.
09/16/2009
Canada · Tape And Bandage, Adhesive
Anji-Yuandong Medical Products Co Ltd
08/05/2016
China · Gauze/Sponge, Nonresorbable For External Use; Bandage, Elastic
Chain Medical Products Co., Ltd.
01/14/2010
China · Tape And Bandage, Adhesive; Dressing, Compression; Gauze/Sponge, Nonresorbable For External Use
Derma Sciences Nantong Inc
10/23/2013
China · Dressing, Wound, Hydrophilic
Dhp Co., Ltd
06/09/2014
China · General & Plastic Surgery; General Hospital/Personal Use
Dongguan City Risen Medical Products Co., Ltd
06/04/2019
China · First aid kit without drug; General & Plastic Surgery; General Hospital/Personal Use
Guangdong Provincial Light Industry
09/16/2009
China · Tape And Bandage, Adhesive
Jiangxi Medicines & Health Products I/E Corp.
09/16/2009
China · Sponge, Gauze; Gauze/Sponge, Nonresorbable For External Use
NANJING HIMED MEDICAL TECHNOLOGY CO., LTD
01/17/2017
China · Tape And Bandage, Adhesive
NINGBO CHINMED TECHNOLOGY CO., LTD
04/13/2016
China · Dressing, Wound, Hydrophilic
Ningbo Chinmed Technology Co. Ltd.
04/13/2016
China · Dressing, Wound, Hydrophilic
Ningbo Chinmed Technology Co. Ltd.
04/13/2016
China · Dressing, Wound, Hydrophilic
Taizhoushi Baisheng Import & Export Trading Co., Ltd.
07/11/2014
China · Gauze/Sponge, Nonresorbable For External Use
WELONG PLASTIC PRODUCTS CO, LTD
02/02/2015
China · Tape And Bandage, Adhesive; Bandage, Elastic
YIWU BANGMEI MEDICAL PRODUCTS
03/03/2015
China · Tape And Bandage, Adhesive; First aid kit without drug
Yangzhou Super-Union Medical Material Co., Ltd.
05/18/2017
China · Tape And Bandage, Adhesive; Kit, First Aid; Gauze/Sponge, Nonresorbable For External Use
Yuyao Chengze Medical Supplies Factory
06/18/2015
China · Tape And Bandage, Adhesive
Zhejiang Bangli Medical Products Co., Ltd
09/16/2009
China · Tape And Bandage, Adhesive; Bandage, Elastic
Zhejiang Hongyu Medical Commodity Co., Ltd.
11/02/2015
China · Dressing, Wound, Hydrophilic; Bandage, Elastic
Fabrik Gmbh Co Kg
09/16/2009
Germany · Tape And Bandage, Adhesive
SUNWAY PHARMACEUTICAL CO. LTD.
09/16/2009
Hong Kong SAR · Tape And Bandage, Adhesive
ABS Medicare Pvt. Ltd.
09/16/2009
India · Dressing, Wound And Burn, Interactive; Dressing, Wound, Hydrogel
Sato Pharmaceutical Co., Ltd
07/20/2010
Japan · Tape And Bandage, Adhesive; Bandage, Elastic
White Medical Ind Inc
09/16/2009
Korea (The Republic Of) · Tape And Bandage, Adhesive
Degasa, S.A. DE C.V
09/16/2009
Mexico · Gauze/Sponge, Nonresorbable For External Use
Laboratorios Jaloma S.A. de C.V.
09/16/2009
Mexico · Gauze/Sponge, Nonresorbable For External Use
Arsons Industries
09/16/2009
Pakistan · Tape And Bandage, Adhesive
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