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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
9/3/2025Eli Lilly Italia SPA

Sesto Fiorentino

ITALYTIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025AstraZeneca UK Ltd.

Macclesfield

UNITED KINDAPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025Glaxo Operations U.K. Ltd.

Barnard Castle

UNITED KINBELIMUMAB
75UNAPPROVED
9/3/2025Patheon Italia S.p.A.

Monza

ITALYRISANKIZUMAB-RZAA
75UNAPPROVED
9/3/2025Bristol Myers Squibb Srl

Anagni

ITALYABATACEPT
75UNAPPROVED
9/3/2025F. Hoffmann - La Roche Ltd.

Kaiseraugst

SWITZERLANTOCILIZUMAB
75UNAPPROVED
9/3/2025Sanofi Winthrop Industrie

Le Trait

FRANCEDUPILUMAB
75UNAPPROVED
9/3/2025Boehringer Ingelheim Hellas A.E.

Koropi

GREECEEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025Lilly S.A.

Alcobendas

SPAINBARICITINIB (ANTI-RHEUMATIC)
75UNAPPROVED
9/3/2025Cilag AG

Schaffhausen

SWITZERLANUSTEKINUMAB
75UNAPPROVED
9/3/2025Pfizer Health AB

Strangnas

SWEDENANAKINRA
75UNAPPROVED
9/3/2025Glaxo Operations UK Limited

Ware

UNITED KINANTI-ASTHMATIC, N.E.C.
75UNAPPROVED
9/3/2025Abbvie Biotechnology Gmbh

Ludwigshafen Am Rhein

GERMANYRISANKIZUMAB-RZAA
75UNAPPROVED
9/3/2025Vetter Pharma Fertigung GmbH & Co. KG

Ravensburg

GERMANYDULAGLUTIDE
75UNAPPROVED
9/3/2025Delpharm Meppel B.V.

Meppel

NETHERLANDMIRABEGRON (ADRENERGIC)
75UNAPPROVED
9/3/2025Bayer AG

Leverkusen

GERMANYRIVAROXABAN
75UNAPPROVED
9/3/2025Novartis Farma S.P.A.

Torre Annunziata

ITALYVALSARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
9/3/2025Sanofi Winthrop Industrie

Tours

FRANCEIMMUNOMODULATOR N.E.C.
75UNAPPROVED
9/3/2025AstraZeneca UK Ltd.

Macclesfield

UNITED KINDAPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025Eli Lilly Italia SPA

Sesto Fiorentino

ITALYDULAGLUTIDE
75UNAPPROVED
9/3/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025Boehringer Ingelheim Pharma GmbH & Co. KG

Ingelheim am Rhein

GERMANYANTI-ASTHMATIC, N.E.C.
75UNAPPROVED
9/3/2025Boehringer Ingelheim Pharma GmbH & Co. KG

Ingelheim am Rhein

GERMANYEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025Pfizer Manufacturing Deutschland GmbH

Freiburg Im Breisgau

GERMANYAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
9/3/2025Pfizer Manufacturing Deutschland GmbH

Freiburg Im Breisgau

GERMANYAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
9/3/2025GlaxoSmithKline Manufacturing S.p.A.

Torrile

ITALYBELIMUMAB
75UNAPPROVED
9/3/2025GlaxoSmithKline Manufacturing S.p.A.

Torrile

ITALYBELIMUMAB
75UNAPPROVED
9/3/2025Glaxo Operations U.K. Ltd.

Barnard Castle

UNITED KINBELIMUMAB
75UNAPPROVED
9/3/2025Wuxi Biologics Co Ltd

Wuxi

CHINAANTINEOPLASTIC, NEC
75UNAPPROVED
9/3/2025Takeda GmbH, Plant Oranienburg

Oranienburg

GERMANYDENTAL PROTECTANT N.E.C.
75UNAPPROVED
9/3/2025Genzyme Ireland Limited

Waterford

IRELANDDUPILUMAB
75UNAPPROVED
9/3/2025Bayer AG

Leverkusen

GERMANYRIVAROXABAN
75UNAPPROVED
9/3/2025Swords Laboratories Unlimited Company

Dublin 15

IRELANDINHIBITOR N.E.C.
75UNAPPROVED
9/3/2025Glaxo Operations UK Limited

Ware

UNITED KINBRONCHODILATOR N.E.C.
75UNAPPROVED
9/3/2025Boehringer Ingelheim Pharma GmbH & Co. KG

Ingelheim am Rhein

GERMANYEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025Swords Laboratories Unlimited Company

Dublin 15

IRELANDNIVOLUMAB
75UNAPPROVED
9/3/2025Pfizer Manufacturing Belgium NV

Puurs-Sint-Amands

BELGIUMETANERCEPT
75UNAPPROVED
9/3/2025Cilag AG

Schaffhausen

SWITZERLANNIVOLUMAB
75UNAPPROVED
9/3/2025Novartis Pharma Stein AG

Stein Ag

SWITZERLANSECUKINUMAB
75UNAPPROVED
9/3/2025Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)

Ravensburg

GERMANYADALIMUMAB
75UNAPPROVED
9/3/2025Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)

Ravensburg

GERMANYVEDOLIZUMAB
75UNAPPROVED
9/3/2025F. Hoffmann - La Roche Ltd.

Kaiseraugst

SWITZERLANOCRELIZUMAB
75UNAPPROVED
9/3/2025Bayer Viatal Gmbh

Leverkusen

GERMANYASPIRIN (ANALGESIC)
75UNAPPROVED
9/3/2025Sanofi-Aventis De Mexico

Ocoyoacac

MEXICOFUROSEMIDE (DIURETIC)
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 75 (UNAPPROVED). Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 301 of 10,077 • Showing records 15,001-15,050 of 503,850 total