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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
9/4/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
9/4/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
9/4/2025NGP TOBACCO APS

Norager

DENMARKNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
9/4/2025NICOTECH OU

Harjumaa

ESTONIANICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
9/4/2025NGP TOBACCO APS

Norager

DENMARKNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
9/4/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
9/4/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
9/4/2025SWEDISH SMOKELESS SOLUTIONS

Jarfalla

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
9/4/2025YOIK AB

Gemla

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
9/4/2025YOIK AB

Gemla

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
9/4/2025YOIK AB

Gemla

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
9/3/2025Micro Therapeutics, Inc.

Irvine

UNITED STAINTRACRANIAL ANEURYSM FLOW DIVERTER
118NOT LISTED
237NO PMA
9/3/2025Micro Therapeutics, Inc.

Irvine

UNITED STAINTRACRANIAL ANEURYSM FLOW DIVERTER
118NOT LISTED
237NO PMA
9/3/2025Micro Therapeutics, Inc.

Irvine

UNITED STAINTRACRANIAL ANEURYSM FLOW DIVERTER
118NOT LISTED
237NO PMA
9/3/2025Micro Therapeutics, Inc.

Irvine

UNITED STAINTRACRANIAL ANEURYSM FLOW DIVERTER
118NOT LISTED
237NO PMA
9/3/2025Micro Therapeutics, Inc.

Irvine

UNITED STAINTRACRANIAL ANEURYSM FLOW DIVERTER
118NOT LISTED
237NO PMA
9/3/2025Micro Therapeutics, Inc.

Irvine

UNITED STAINTRACRANIAL ANEURYSM FLOW DIVERTER
118NOT LISTED
237NO PMA
9/3/2025Micro Therapeutics, Inc.

Irvine

UNITED STAINTRACRANIAL ANEURYSM FLOW DIVERTER
118NOT LISTED
237NO PMA
9/3/2025Micro Therapeutics, Inc.

Irvine

UNITED STAINTRACRANIAL ANEURYSM FLOW DIVERTER
118NOT LISTED
237NO PMA
9/3/2025Micro Therapeutics, Inc.

Irvine

UNITED STAINTRACRANIAL ANEURYSM FLOW DIVERTER
118NOT LISTED
237NO PMA
9/3/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
9/3/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
9/3/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
9/3/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
9/3/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
9/3/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
9/3/2025SANOFI AVENTIS FRANCE LABORATORY

Paris

FRANCEINSULIN GLARGINE
118NOT LISTED
75UNAPPROVED
9/3/2025RAVINDRA MARUTI DASWANT

Pune

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
9/3/2025RAVINDRA MARUTI DASWANT

Pune

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
9/3/2025RAVINDRA MARUTI DASWANT

Pune

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
9/3/2025RAVINDRA MARUTI DASWANT

Pune

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
9/3/2025RAVINDRA MARUTI DASWANT

Pune

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
9/3/2025RAVINDRA MARUTI DASWANT

Pune

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
9/3/2025RAVINDRA MARUTI DASWANT

Pune

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
9/3/2025RAVINDRA MARUTI DASWANT

Pune

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
9/3/2025RAVINDRA MARUTI DASWANT

Pune

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
9/3/2025RAVINDRA MARUTI DASWANT

Pune

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
9/3/2025RAVINDRA MARUTI DASWANT

Pune

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
9/3/2025RAVINDRA MARUTI DASWANT

Pune

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
9/3/2025Zoetis LLC

Kalamazoo

UNITED STASAROLANER (ANTIPARASITIC)
75UNAPPROVED
9/3/2025Amgen Europe BV

Breda

NETHERLANDDENOSUMAB
75UNAPPROVED
9/3/2025Eli Lilly Italia SPA

Sesto Fiorentino

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

Torrile

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

Torrile

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

Monza

ITALYRISANKIZUMAB-RZAA
75UNAPPROVED
9/3/2025Patheon Italia S.p.A.

Monza

ITALYRISANKIZUMAB-RZAA
75UNAPPROVED
9/3/2025Novo Nordisk A/S - 25a-B

Hillerod

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025Novo Nordisk A/S - 25a-B

Hillerod

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
9/3/2025Novartis Farma S.P.A.

Torre Annunziata

ITALYVALSARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
9/3/2025Boehringer Ingelheim Pharma GmbH & Co. KG

Ingelheim am Rhein

GERMANYANTI-ASTHMATIC, N.E.C.
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 10 countries. Records on this page involve violations including 3842 (TP NO PMTA), 3843 (TP NO SE), 3854 (TPLKUSSLLB), 118 (NOT LISTED), 237 (NO PMA) and 1 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 300 of 10,077 • Showing records 14,951-15,000 of 503,850 total