ImportRefusal LogoImportRefusal

Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/14/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/13/2025Paritec Gmbh

Weilheim i. OB

GERMANYNEBULIZER (DIRECT PATIENT INTERFACE)
118NOT LISTED
3280FRNMFGREG
+1 more
11/13/2025Paritec Gmbh

Weilheim i. OB

GERMANYNEBULIZER (DIRECT PATIENT INTERFACE)
118NOT LISTED
3280FRNMFGREG
+1 more
11/13/2025Paritec Gmbh

Weilheim i. OB

GERMANYNEBULIZER (DIRECT PATIENT INTERFACE)
118NOT LISTED
3280FRNMFGREG
+1 more
11/13/2025Paritec Gmbh

Weilheim i. OB

GERMANYNEBULIZER (DIRECT PATIENT INTERFACE)
118NOT LISTED
3280FRNMFGREG
+1 more
11/13/2025COSRX INC

Seongnam

SOUTH KOREDRESSING, WOUND, DRUG
118NOT LISTED
3280FRNMFGREG
+2 more
11/13/2025AbbVie Inc.

North Chicago

UNITED STAONABOTULINUMTOXINA
118NOT LISTED
3280FRNMFGREG
+1 more
11/13/2025Cipca Ltd

Goa

INDIAALBUTEROL (BRONCHODILATOR)
118NOT LISTED
3280FRNMFGREG
11/13/2025OMEGA BIOTECH LTD

Roorkee

INDIAERYTHROMYCIN (MACROLIDES)
118NOT LISTED
3280FRNMFGREG
11/13/2025Alkem Laboratories Pvt Ltd

Hyderabad

INDIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
118NOT LISTED
3280FRNMFGREG
11/13/2025ALEMBIC

Mumbai

INDIAERYTHROMYCIN (MACROLIDES)
118NOT LISTED
3280FRNMFGREG
11/13/2025Cipla

Haridwar

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
11/13/2025Pfizer Manufacturing Deutschland GmbH

Freiburg Im Breisgau

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
11/13/2025Astonea Labs Private Limited

Distt. Panchkula

INDIALIDOCAINE (ANESTHETIC)
118NOT LISTED
3280FRNMFGREG
11/13/2025Astonea Labs Private Limited

Distt. Panchkula

INDIABACITRACIN ZINC (PEPTIDES)
118NOT LISTED
3280FRNMFGREG
11/13/2025ALTRUAN GMBH

Massing

GERMANYNEEDLE, HYPODERMIC, SINGLE LUMEN
118NOT LISTED
3280FRNMFGREG
11/13/2025DHNP

Gyeonggi-Do

SOUTH KOREOTHER COSMETIC RAW MATERIALS, N.E.C.
118NOT LISTED
3260NO ENGLISH
+2 more
11/13/2025GUANGZHOU PLUSLIFE BIOTECH CO. LTD.

Guangzhou

CHINACOVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES
118NOT LISTED
237NO PMA
+2 more
11/13/2025Allergan Industrie SAS

Pringy

FRANCEIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
11/13/2025IBSA Farmaceutici Italia Srl

Lodi

ITALYACID, HYALURONIC, INTRAARTICULAR
118NOT LISTED
237NO PMA
+1 more
11/13/2025SBL Private Limited

East Delhi

INDIAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
11/13/2025SBL Private Limited

East Delhi

INDIAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
11/13/2025Vichy Lab

Paris 8e Arrondissement

FRANCEALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
11/13/2025VICHY

Vichy

FRANCEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
11/13/2025Eucerin

Hamburg

GERMANYULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
11/13/2025I.F. CANTABRIA

Santander

SPAINULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
11/13/2025E11EMENT INC.

Scarborough

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 10 countries. Records on this page involve violations including 3854 (TPLKUSSLLB), 118 (NOT LISTED), 3280 (FRNMFGREG), 508 (NO 510(K)), 341 (REGISTERED) and 3 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 86 of 10,038 • Showing records 4,251-4,300 of 501,854 total