FDA import alert

Import Alert 66-40

Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs

466

Red-list entries

0

Green-list entries

55

Countries

2026-08-14

Last change seen

Official FDA source ↗Data refreshed 2026-08-27 UTC

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

Firms on this red list

Showing 100 of 466 entries — search a specific firm on the free checker.

  • 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

  • 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 · 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

  • 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

  • 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

  • Australia · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Australia · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Australia · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Australia · Miscellaneous Patent Medicines, Etc., Human - Investigational, Small Volume Parenteral <100ml

  • 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

  • Australia · Paste Masks (Mud Packs) (Skin Care Preparations); Other Suntan Preparations (not Sunscreen), N.E.C.; Pharm Necess & Ctnr For Drug/Bio

  • Austria · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs

  • Bahamas · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Bahamas · Aid, Surgical, Viscoelastic

  • Belgium · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs

  • Brazil · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • 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

  • 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

  • Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Canada · Cosmetics; Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Canada · Cosmetics; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • Canada · Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent); Potassic Saline (Injection) (Replenisher)

  • Canada · Cosmetic Prods Containing Animal By Prod (Ovine); Mineral; Pharm Necess & Ctnr For Drug/Bio

  • Canada · Cosmetics; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Canada · Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Not Elsewhere Classified (NEC); 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

  • Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Canada · 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

  • Canada · Cosmetics; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio

  • Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Homeocan Inc

    05/03/2017

    Canada · Cosmetics; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio

  • Homeocan Inc

    05/03/2017

    Canada · Cosmetics; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio

  • Canada · Cosmetics; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio

  • Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Canada · Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs; Human and Animal Drugs

  • Canada · Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Canada · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • Canada · 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

  • China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • 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

  • China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • China · Cosmetics; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • 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

  • 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

  • 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

  • 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

  • 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

  • China · Color Additiv Food/Drug/Cosmetic; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • 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

  • China · Crude Heparin (Pharmaceutic Necessity); Pharmaceutic Necessities, N.E.C.; Whole Blood (Human) Heparin (Blood and Blood Derivatives)

  • China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • 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

  • 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

  • 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

  • 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

  • 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

  • China · Cosmetics; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • China · Cosmetics; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • China · Personal Cleanliness; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • 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

  • 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

  • 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

  • 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

  • China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • China · Cosmetics; 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

  • China · A-Bacterial Pt. II (Not Antibiotic); A-Bacterial Pt. III (Not Antibiotic)

  • 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

  • China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • 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

  • 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

  • China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • China · Cosmetics; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • 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

  • China · Cosmetics; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • 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

  • China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • China · Other Personal Cleanliness Products (not Antiperspirant), N.E.C.; Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal)

  • China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs

  • 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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