FDA import alert
Import Alert 66-40
Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs
462
Red-list entries
0
Green-list entries
55
Countries
2026-07-09
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
Firms on this red list
Showing 30 of 462 entries — search a specific firm on the free checker.
BABIKIAN HEALTHCARE PRODUCTS
06/22/2026
Armenia · 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
Babikian Healthcare Products, CJSC
06/22/2026
Armenia · 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
Aruba Aloe Balm N.V.
04/15/2024
Aruba · 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
Antaria Pty. Ltd.
01/08/2026
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
Cosmetic Manufacturers (Aust) Pty Ltd.
01/08/2026
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
Delta Laboratories Pty Ltd
09/28/2017
Australia · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Jalco Cosmetics Pty Ltd.
03/08/2018
Australia · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Natural Beauty Care Pty Ltd
03/23/2021
Australia · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Radpharm Scientific
09/10/2009
Australia · Miscellaneous Patent Medicines, Etc., Human - Investigational, Small Volume Parenteral <100ml
Veganic SKN Limited
01/08/2026
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
Wild Child Laboratories Pty Ltd.
10/28/2022
Australia · Paste Masks (Mud Packs) (Skin Care Preparations); Other Suntan Preparations (not Sunscreen), N.E.C.; Pharm Necess & Ctnr For Drug/Bio
Schrofner Cosmetics Gmbh
10/20/2017
Austria · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
Coral Pharmaceuticals LTD
09/25/2019
Bahamas · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Howard Medical International
01/25/2021
Bahamas · Aid, Surgical, Viscoelastic
Laboratoria Qualiphar NV
01/18/2011
Belgium · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
Cartibras Beneficiadora De Produtos Animais Ltda
04/13/2020
Brazil · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Lima & Pergher Industria e Comercio S/A
07/15/2016
Brazil · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
FICOSOTA LTD
01/10/2020
Bulgaria · Lotions, Oils, Powders and Creams (Baby Products); Other Baby Products, N.E.C.; Pharm Necess & Ctnr For Drug/Bio
8046255 Canada Inc. DBA Viatrexx
10/09/2019
Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
AG Hair Ltd.
10/28/2022
Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Aleeda Inc
05/29/2012
Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs
Attix Pharmaceuticals Inc.
02/18/2015
Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Avaria Health & Beauty Corp.
04/14/2023
Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Aztex Enterprises Ltd.
10/19/2017
Canada · Cosmetics; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
Aztex Enterprises Ltd.
10/19/2017
Canada · Cosmetics; Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs
Baxter Healthcare
04/10/2014
Canada · Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent); Potassic Saline (Injection) (Replenisher)
Bill Beauty and Health Products Ltd.
07/24/2018
Canada · Cosmetic Prods Containing Animal By Prod (Ovine); Mineral; Pharm Necess & Ctnr For Drug/Bio
Bodywell Natural Skin Care Inc.
02/05/2024
Canada · Cosmetics; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)
Brands International Corporation
10/28/2024
Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
CMI Cosmetic Manufacturers Inc.
09/28/2015
Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Does this alert touch your supply chain?
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