FDA import alert
Import Alert 66-79
Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection
274
Red-list entries
0
Green-list entries
22
Countries
2026-06-22
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
Firms on this red list
Showing 30 of 274 entries — search a specific firm on the free checker.
MEDIA NETWORKS SYDNEY PTY LIMITED
07/09/2025
Australia · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
PLANET LUXE OPERATIONS PTY LTD
09/29/2023
Australia · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Unibeleza Industria E Comercio De Cosmeticos Ltda
10/18/2022
Brazil · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Beattie's Distillers Inc
08/02/2023
Canada · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
Anfei Technology Co., Limited
10/13/2022
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Anhui Province Yifan Spice Co.,Ltd
10/13/2022
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Baoying County Fukang Medical Appliance Co., Ltd.
10/13/2022
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Beijing Shunxin Meihua Bio-technical Co., Ltd.
10/13/2022
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Beijing Taiyang Pharmaceutical Industry Company Ltd
10/13/2022
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Beyond Technology Corporation Nanchang
10/13/2022
China · Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products); Other Oral Hygiene Products, without Fluoride, N.E.C.; Pharm Necess & Ctnr For Drug/Bio
Binzhou Hengfeng Biotechnology Co., Ltd.
10/28/2025
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
Bluebay Shandong Co., Ltd
04/08/2024
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
Changsha Aoyisen Biotechnology Co., Ltd.
01/27/2025
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
Changsha Macond Chemical Co., Ltd.
07/22/2025
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
Changsha Puhesi Chemical Technology Co., Ltd.
03/26/2025
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
Chengdu Aiying Bio-Technology Co.,Ltd
12/19/2022
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Chengdu KeCheng Fine Chemicals Co., Ltd.
06/08/2023
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Chengdu Miao Ding Xin Pharmaceutical Technology Co., Ltd.
07/03/2025
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
Chengdu Rui Bei Yuan Bio-Pharmaceutical Technology Co., Ltd.
09/25/2024
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
Chengdu Weihuitai Pharmaceutical Technology Co., Ltd.
06/12/2025
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
Chifeng Wanze Pharmaceutical Co., Ltd
10/13/2022
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Chongqing Dijiasuo Pharmaceutical Technology Co., Ltd.
06/16/2025
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
Dong Yuan Technology Co., Ltd.
04/21/2025
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
Dongguan Chunzhen Biotechnology Co., Ltd.
10/13/2022
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Dongguan Mingyi Medical Products Co., Ltd.
01/05/2023
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Enlightening Pallet Industry Co., Limited
03/23/2026
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
Foshan Meixin Biotechnology Co., Ltd
04/24/2023
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Foshan Nanhai Jiachun Biology Engineering Co., Ltd.
10/13/2022
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Fuzhou Hongyisheng Pharmatech Co., Ltd
04/04/2025
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
Fuzhou Jianyu Chemical Technology Co., Ltd.
09/26/2024
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr
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