FDA import alert
Import Alert 66-78
Detention Without Physical Examination of Drugs, Based Upon Analytic Test Results
77
Red-list entries
0
Green-list entries
7
Countries
2023-05-09
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 |
|---|---|
| Mexico | 57 |
| China | 11 |
| Korea (The Republic Of) | 5 |
| Dominican Republic (The) | 1 |
| Guatemala | 1 |
| Poland | 1 |
| Turkey | 1 |
Firms on this red list
Showing 30 of 77 entries — search a specific firm on the free checker.
GUANGDONG KEMEI PHARMACEUTICAL TECHNOLOGY CO LTD
01/07/2021
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Guangzhou Minghui Cosmetics Co., Ltd.
12/21/2020
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Guangzhou Shiruoni Cosmetics Co., Ltd
03/10/2021
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Guangzhou Yapeng Refinement Chemical Co., Ltd
03/10/2021
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Guangzhou Youxing Cosmetic Co., Ltd
10/08/2020
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Guangzhou Zhongkebaishi Health Industry Co., Ltd.
03/29/2021
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Hou Fu Biotech (Jiangsu) Co., Ltd
12/03/2020
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Ningbo Haishu Huasen Houseware Co., Ltd
04/21/2022
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Ningbo Haishu Huayu Industrial & Trade Co., Ltd.
04/22/2022
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
ShangRao Chunyu Technology Co., Ltd.
11/06/2020
China · Cosmetics; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
ZHEJIANG SANYUANSE COSMETICS CO LTD
04/21/2022
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Ardil Comercial S.R.L.
06/30/2021
Dominican Republic (The) · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Genesis Partnership Company SA
09/02/2020
Guatemala · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
AriBio H&B
03/04/2021
Korea (The Republic Of) · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
David Cosmetic
03/10/2022
Korea (The Republic Of) · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
David Cosmetic Co., Ltd.
03/10/2022
Korea (The Republic Of) · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
DongBang Cosmetics Co., Ltd.
01/11/2021
Korea (The Republic Of) · Other Personal Cleanliness Products (not Antiperspirant), N.E.C.; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
Mirfeel Korea Co., Ltd
03/24/2022
Korea (The Republic Of) · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
4E Global, S.A.P.I. de C.V.
07/16/2020
Mexico · Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness); Other Personal Cleanliness Products (not Antiperspirant), N.E.C.; Pharm Necess & Ctnr For Drug/Bio
AAA Cosmetica, SA de CV
07/07/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
ABSARA COSMETICS SAPI DE CV
02/04/2021
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Absara Cosmetics S.A.P.I DE C.V.
02/04/2021
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Albek De Mexico S.A. De C.V.
08/04/2020
Mexico · Other Personal Cleanliness Products (not Antiperspirant), N.E.C.; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
Asesores en Mantenimiento Hidraulico e Industrial, S.A. de C.V.
09/02/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Asiaticon, SA de CV
08/11/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Botanicals Internacional S.A. de C.V.
08/13/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Broncolin, S.A. de C.V.
07/29/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
C&G Laboratorios SA de CV
10/09/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
CORPORATIVO BURELI SA DE CV
09/24/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
DDI MULTINACIONAL SA DE CV
07/13/2020
Mexico · Other Personal Cleanliness Products (not Antiperspirant), N.E.C.; Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations); Pharm Necess & Ctnr For Drug/Bio
Does this alert touch your supply chain?
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