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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
11/3/2025Amgen, Inc.

Thousand Oaks

UNITED STAETANERCEPT
179AGR RX
11/3/2025Amgen, Inc.

Thousand Oaks

UNITED STAIMMUNOLOGICAL AGENT, NEC
179AGR RX
11/3/2025ALLERGAN INC./ABBVIE INC

North Chicago

UNITED STAONABOTULINUMTOXINA
179AGR RX
11/3/2025Eli Lilly & Company

Indianapolis

UNITED STAIXEKIZUMAB
179AGR RX
11/3/2025Janssen Biotech, Inc.

Malvern

UNITED STAGUSELKUMAB
179AGR RX
11/3/2025AbbVie Inc.

North Chicago

UNITED STARISANKIZUMAB-RZAA
179AGR RX
11/3/2025Amgen Manufacturing Limited LLC

Juncos

UNITED STAETANERCEPT
179AGR RX
11/3/2025Regeneron Pharmaceuticals Inc

Rensselaer

UNITED STADUPILUMAB
179AGR RX
11/3/2025Eli Lilly & Company

Indianapolis

UNITED STAIXEKIZUMAB
179AGR RX
11/3/2025SHENZHEN LVSHIYUAN BIOTECHNOLOGY

Shenzhen

CHINAOVER-THE-COUNTER COVID-19 ANTIGEN TEST
118NOT LISTED
476NO REGISTR
+1 more
11/3/2025FANCY PLASTIC (SU ZHOU) CO LTD

Su Zhou

CHINATUBE, ASPIRATING, FLEXIBLE, CONNECTING
118NOT LISTED
476NO REGISTR
11/3/2025Menicon Co., Ltd.

Nagoya

JAPANLENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
476NO REGISTR
11/3/2025Sandoz GmbH

Langkampfen

AUSTRIAADALIMUMAB-ADAZ
118NOT LISTED
11/3/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
118NOT LISTED
11/3/2025Sun Pharmaceutical Industries Ltd

Mumbai

INDIAEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
11/3/2025SOUL PHARMA

Nagpur

INDIAEZETIMIBE
75UNAPPROVED
11/3/2025SOUL PHARMA

Nagpur

INDIABIMATOPROST (PROSTAGLANDIN)
75UNAPPROVED
11/3/2025VENOGEN

Subang Jaya

MALAYSIASEDATIVE N.E.C.
75UNAPPROVED
11/3/2025VENOGEN BIOCHEMICALS

Hong Kong

HONG KONGEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
11/3/2025Norma Corahbet Salazar Silva dba Garapinados Aarkor SA DE CV

Santiago

MEXICOCARAMEL CANDY PIECES, SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
11/3/2025GULF UNION FOODS COMPANY

Riyadh

SAUDI ARABFRUIT COCTAIL, MIXED FRUIT, JUICES OR CONCENTRATES
11UNSAFE COL
218LIST INGRE
+3 more
11/3/2025GULF UNION FOODS COMPANY

Riyadh

SAUDI ARABFRUIT COCTAIL, MIXED FRUIT, JUICES OR CONCENTRATES
11UNSAFE COL
218LIST INGRE
+5 more
11/3/2025IMPERIAL TEA EXPORTS (PVT) LTD

Gampaha District

SRI LANKACINNAMON, CASSIA, GROUND, CRACKED (SPICE)
9SALMONELLA
11/3/2025Not Supplied-CINNAMON, CASSIA, GROUND, CRACKED (SPICE)
9SALMONELLA
11/2/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/2/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/2/2025Frutabella Ind e Com de Alimentos Ltda

Lagoa Santa

BRAZILCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH FRUIT (WITHOUT CHOCOLATE)
3600REFUSE EI
3846807REFUSAL
11/2/2025Frutabella Ind e Com de Alimentos Ltda

Lagoa Santa

BRAZILCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH FRUIT (WITHOUT CHOCOLATE)
3600REFUSE EI
3846807REFUSAL
11/2/2025NESTLE INDIA LIMITED

AHMEDABAD

INDIANOODLES, VEGETABLE
218LIST INGRE
238UNSAFE ADD
11/2/2025NESTLE INDIA LIMITED

AHMEDABAD

INDIANOODLES, VEGETABLE
218LIST INGRE
238UNSAFE ADD
11/2/2025EMPRESA BRASILEIRA DE BEBIDAS E ALIMENTOS SA

Aracati

BRAZILSUBTROPICAL/TROPICAL, MIXED, JUICES OR CONCENTRATES
83NO PROCESS
11/2/2025EMPRESA BRASILEIRA DE BEBIDAS E ALIMENTOS SA

Aracati

BRAZILSUBTROPICAL/TROPICAL, MIXED, JUICES OR CONCENTRATES
83NO PROCESS
11/2/2025EMPRESA BRASILEIRA DE BEBIDAS E ALIMENTOS SA

Aracati

BRAZILSUBTROPICAL/TROPICAL, MIXED, JUICES OR CONCENTRATES
83NO PROCESS
11/2/2025EMPRESA BRASILEIRA DE BEBIDAS E ALIMENTOS SA

Aracati

BRAZILSUBTROPICAL/TROPICAL, MIXED, JUICES OR CONCENTRATES
83NO PROCESS
11/2/2025FINPRO CAPITAL SERVICES

Mumbai

INDIAHENNA
11UNSAFE COL
11/1/2025Swedish Match Ab

Stockholm

SWEDENSNUS
3854TPLKUSSLLB
11/1/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
11/1/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
11/1/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/1/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/1/2025Swedish Match Ab

Stockholm

SWEDENSMOKELESS TOBACCO POUCHES
3854TPLKUSSLLB
11/1/2025Swedish Match Ab

Stockholm

SWEDENSMOKELESS TOBACCO POUCHES
3854TPLKUSSLLB
11/1/2025Swedish Match Ab

Stockholm

SWEDENSMOKELESS TOBACCO POUCHES
3854TPLKUSSLLB
11/1/2025Swedish Match Ab

Stockholm

SWEDENENDS DIGITAL DISPLAY/LIGHTS
3854TPLKUSSLLB
11/1/2025LIW INNOVATION AB

Hokerum

SWEDENSNUS
3842TP NO PMTA
11/1/2025LIW INNOVATION AB

Hokerum

SWEDENSNUS
3842TP NO PMTA
11/1/2025MICROZERO AB

Goteborg

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/1/2025MICROZERO AB

Goteborg

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/1/2025CK FULFILMENT

Preston

UNITED KINORTHODONTIC LED ACCESSORY
118NOT LISTED
3280FRNMFGREG
+1 more
11/1/2025COLGATE PALMOLIVE

Cali

COLOMBIASODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
3280FRNMFGREG

About This Page

This page displays 50 FDA import refusal records from 16 countries. Records on this page involve violations including 179 (AGR RX), 118 (NOT LISTED), 476 (NO REGISTR), 508 (NO 510(K)), 75 (UNAPPROVED) and 16 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 158 of 10,077 • Showing records 7,851-7,900 of 503,850 total