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.
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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 77 of 77 entries — search a specific firm on the free checker.
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
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
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
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)
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
- DEPQ Internacional S. de R.L de C.V.
07/31/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- DIBAR NUTRICIONALS S DE RL DE CV
06/22/2021
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- DMM Vission, 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
- Datsen SA DE CV'
07/15/2020
Mexico · Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
- Dibar Nutricional S. de R.L. de C.V.
06/22/2021
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- ESTRATEGIA HOSPITALARIA SA DE CV
08/14/2020
Mexico · Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
- Eskbiochem SA de CV
07/15/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- GRUPO YACANA MEXICO SAS DE CV
08/20/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- GRUPO YACANA MEXICO SAS DE CV
08/20/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Grupo Asimex de Mexico SA de CV
08/17/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Grupo Insoma, S.A.P.I de CV
07/10/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Grupo Plast-Y-Kosas, SA de CV
08/11/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- HARMONIC NATURE S DE RL MI
08/20/2020
Mexico · Other Personal Cleanliness Products (not Antiperspirant), N.E.C.; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Ignacio Reyes Gonzalez
08/21/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Incredible Products, SA de CV
08/13/2020
Mexico · Shampoos (Hair Preparations, Non-coloring); Other Hair Preparations, Non-coloring), N.E.C.; Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
- Industrias Cklass S de RL de CV
09/14/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Inovaker Lab SA de CV
10/02/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Ismar Soluciones Dinamicas SA de CV
08/14/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- JG Atlas Comercios, SA de CV
08/07/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- JOSE MIGUEL GUTIERREZ SALAS
09/01/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Laavo Clean, S.A. de C.V.
05/09/2023
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Laboratorios Jaloma S.A. de C.V.
08/03/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Limpo Quimicos, SA de CV
07/15/2020
Mexico · Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
- Liq-E S.A. De C.V.
07/15/2020
Mexico · Other Personal Cleanliness Products (not Antiperspirant), N.E.C.; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
- MXL Comercial, SA de CV
07/24/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- MYM Hidrominerales S. de RL. de C.V.
08/27/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Maquiladora Miniara SA de CV
07/16/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Marco Antonio Rodriguez Fierro
09/28/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Nanomateriales, SA de CV
08/31/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Neoingenium Labs, SA de CV
09/18/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Notarika S.A. de CV
08/11/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Notarika, S.A. de C.V.
08/11/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Plasticos Las Palmas, S.A. de C.V.
08/06/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Quimica Magna de Mexico, S.A. de C.V.
07/15/2020
Mexico · Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
- Real Clean Distribuciones SA de CV
07/16/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Roque Plast 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
- Simex Logistics SA de CV
11/17/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Soluciones Cosmeticas, SA de CV
07/10/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Tropicosmeticos, S.A. de C.V.
07/10/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- YARA ELENA DE LA GARZA PEREZ NIETO
07/17/2020
Mexico · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
- BIONATEO SP ZOO
06/07/2021
Poland · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Turkey · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
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