FDA import alert
Import Alert 77-01
Detention Without Physical Examination Of Ear Candles
23
Red-list entries
0
Green-list entries
8
Countries
2018-08-21
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 |
|---|---|
| Canada | 10 |
| Australia | 4 |
| China | 3 |
| United Kingdom | 2 |
| Germany | 1 |
| Hungary | 1 |
| Italy | 1 |
| New Zealand | 1 |
Firms on this red list
Showing 23 of 23 entries — search a specific firm on the free checker.
Byron Bay Ear Candles
08/23/2010
Australia · Ear,Nose And Throat
Ear Candles Australia
08/23/2010
Australia · Ear,Nose And Throat
Happy Natural Therapies
08/23/2010
Australia · Ear,Nose And Throat
Helio Supply Co Pty Ltd
08/21/2018
Australia · Ear,Nose And Throat
AURAL
08/21/2018
Canada · Ear,Nose And Throat
Ancient Future of Health
08/23/2010
Canada · Ear,Nose And Throat
Debbie Boehlen dba Queen Bee Ear Candles
08/21/2018
Canada · Ear,Nose And Throat
Europa Cosmetics Ltd
08/21/2018
Canada · Ear,Nose And Throat
Harmony Horizons
08/23/2010
Canada · Ear,Nose And Throat
Natruadif/Aurys Distribution
08/23/2010
Canada · Ear,Nose And Throat
Pheylonian Production Kohr
08/23/2010
Canada · Ear,Nose And Throat
Soully Created
08/23/2010
Canada · Ear,Nose And Throat
Super Natural Health Product
08/23/2010
Canada · Ear,Nose And Throat
Susan's Ear Candles
08/23/2010
Canada · Ear,Nose And Throat
Huaren Ec Co Ltd
06/20/2013
China · Ear irrigation kit
SDC Company
08/21/2018
China · Ear,Nose And Throat
Suzhou Helio Technology, Co. Ltd.
08/21/2018
China · Ear,Nose And Throat
Biosun Gmbh
08/23/2010
Germany · Ear,Nose And Throat
Naturhelix Ltd.
08/23/2010
Hungary · Ear,Nose And Throat
OTOSAN
08/21/2018
Italy · Ear,Nose And Throat
Ear Candles by Louise
08/23/2010
New Zealand · Ear,Nose And Throat
Blue Banyon Ltd
08/23/2010
United Kingdom · Ear,Nose And Throat
Oxford Medical Supplies Ltd
08/21/2018
United Kingdom · Ear,Nose And Throat
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