FDA import alert
Import Alert 78-01
Detention Without Physical Examination Of External Penile Rigidity Devices
6
Red-list entries
0
Green-list entries
2
Countries
2024-05-21
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 |
|---|---|
| China | 4 |
| United Kingdom | 2 |
Firms on this red list
Showing 6 of 6 entries — search a specific firm on the free checker.
GIZMOSPRING.COM DONGGUAN LIMITED
01/12/2015
China · Device, External Penile Rigidity
Lovetoys Industrial Co Ltd
04/07/2015
China · Device, External Penile Rigidity; Massager, Therapeutic, Electric; Massager, Therapeutic, Manual
SHENZHEN CANWIN HEALTH PRODUCTS CO., LTD
04/20/2016
China · Device, External Penile Rigidity
Shenzhen Hong Ji Pu Technology Co., Ltd.
06/24/2016
China · Device, External Penile Rigidity
ENGINEERED INNOVATION
05/21/2024
United Kingdom · Device, External Penile Rigidity
UM Products Ltd
04/06/2015
United Kingdom · Device, External Penile Rigidity; Massager, Therapeutic, Electric
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