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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
11/4/2025CROMA-PHARMA GMBH

Leobendorf

AUSTRIAIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
11/4/2025CROMA-PHARMA GMBH

Leobendorf

AUSTRIAIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
11/4/2025MANSOOR ALI ISA

Dubai

UNITED ARALENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
118NOT LISTED
235NOT IMPACT
+3 more
11/4/2025LUCIUS PHARMACEUTICALS

Vientiane

LAOSMISCELLANEOUS ANTIBIOTICS, N.E.C.
118NOT LISTED
75UNAPPROVED
11/4/2025MEMPHIS

Bogota

COLOMBIAAZITHROMYCIN (MACAROLIDES)
118NOT LISTED
75UNAPPROVED
11/4/2025OPHALAC

Bogota

COLOMBIACEPHALOSPORIN N.E.C.
118NOT LISTED
75UNAPPROVED
11/4/2025Laproff

Medellin

COLOMBIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
118NOT LISTED
75UNAPPROVED
11/4/2025Memphis Products S.A.

Bogota

COLOMBIACLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS)
118NOT LISTED
75UNAPPROVED
11/4/2025LABORATORIOS FARMASER

Cali

COLOMBIAACETAMINOPHEN (ANALGESIC)
118NOT LISTED
75UNAPPROVED
11/4/2025Claripack

Bogota

COLOMBIAIBUPROFEN (ANTI-INFLAMMATORY)
118NOT LISTED
75UNAPPROVED
11/4/2025LABOREX KENA LTD

Nairobi

KENYAAPIXABAN (ANTI-COAGULANT)
118NOT LISTED
75UNAPPROVED
11/4/2025Cosmax Inc

Gyeonggi-do

SOUTH KOREOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
11/4/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINESAUCES, N.E.C.
11UNSAFE COL
482NUTRIT LBL
11/4/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINESAUCES, N.E.C.
11UNSAFE COL
482NUTRIT LBL
11/4/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINESAUCES, N.E.C.
11UNSAFE COL
482NUTRIT LBL
11/4/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINESAUCES, N.E.C.
11UNSAFE COL
482NUTRIT LBL
11/4/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
11/4/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
11/4/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
11/4/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
11/3/2025BEYOGLU CIKOLATA SANAYI TICARET ANONIM SIRKETI KILIS 3 SUBESI

Merkez

TURKEYCHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT)
3865COLORLABEL
11/3/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
11/3/2025CHAINPOP AB

Goteborg

SWEDENSNUS
3842TP NO PMTA
3843TP NO SE
11/3/2025LIW INNOVATION AB

Hokerum

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
11/3/2025LIW INNOVATION AB

Hokerum

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
11/3/2025Gn Tobacco Sweden Ab

Bispgarden

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
11/3/2025APRES NICOTINE AB

Vetlanda

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
11/3/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
11/3/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
11/3/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
11/3/2025Bio-Gen Milchserum Marketing GmbH

Montabaur

GERMANYVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3560SUPPL GMP
11/3/2025Bio-Gen Milchserum Marketing GmbH

Montabaur

GERMANYVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3560SUPPL GMP
11/3/2025HC Biologics LLC

Miami

UNITED STABONE
478TISSUE
11/3/2025GIRORGANIC

Kamrej

INDIABUTTER OIL
473LABELING
482NUTRIT LBL
11/3/2025GIRORGANIC

Kamrej

INDIABUTTER OIL
473LABELING
482NUTRIT LBL
11/3/2025GIRORGANIC

Kamrej

INDIABUTTER OIL
473LABELING
482NUTRIT LBL
11/3/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIAFRIED SNACK FOODS, N.E.C.
308MFR INSAN
3821MFR INJ
+1 more
11/3/2025G.D. FOODS MFG (I) PVT. LTD.

New Delhi

INDIAPEPPER,BLACK, WHOLE (SPICE)
249FILTHY
9SALMONELLA
11/3/2025CAPITAL FOODS PRIVATE LIMITED

Bhilad

INDIANOODLES AND NOODLE PRODUCTS, N.E.C.
249FILTHY
11/3/2025KUMBAGIRI RANGAREDDY

Guntur

INDIATAMARIND (SUBTROPICAL AND TROPICAL FRUIT)
249FILTHY
11/3/2025G. D. FOODS MFG INDIA PVT LTD.

New Delhi

INDIATAMARIND (SUBTROPICAL AND TROPICAL FRUIT PUREES)
249FILTHY
11/3/2025Life Pharma

Kabul

AFGHANISTARAISINS, DRIED OR PASTE
241PESTICIDE
11/3/2025QUYNH ANH AQUATIC PRODUCT IMPORT EXPORT BUSINESS COMPANY LIMITED

Thu Duc

VIETNAMMUSHROOM, STRAW, FUNGI PRODUCTS, N.E.C.
241PESTICIDE
11/3/2025CANHAIDOM TRADING

Port Au Pprince

HAITIMALT, RICE
218LIST INGRE
324NO ENGLISH
11/3/2025CANHAIDOM TRADING

Port Au Pprince

HAITIPLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
218LIST INGRE
11/3/2025CANHAIDOM TRADING

Port Au Pprince

HAITICASSAVA, DRIED OR PASTE
218LIST INGRE
11/3/2025AbbVie Inc.

North Chicago

UNITED STAADALIMUMAB
179AGR RX
11/3/2025Novartis Pharmaceuticals Corporation

Morris Plains

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

Malvern

UNITED STAUSTEKINUMAB
179AGR RX
11/3/2025Sanofi Aventis Pharmaceuticals

Rensselaer

UNITED STADUPILUMAB
179AGR RX

About This Page

This page displays 50 FDA import refusal records from 17 countries. Records on this page involve violations including 118 (NOT LISTED), 237 (NO PMA), 3280 (FRNMFGREG), 235 (NOT IMPACT), 508 (NO 510(K)) and 18 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 157 of 10,077 • Showing records 7,801-7,850 of 503,850 total