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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
7/24/2025HKM Farmacia de Manipulacao Ltda

Palhoca

BRAZILCOENZYME Q10 (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)
75UNAPPROVED
7/24/2025HKM Farmacia de Manipulacao Ltda

Palhoca

BRAZILPROGESTERONE (PROGESTIN)
75UNAPPROVED
7/24/2025HKM Farmacia de Manipulacao Ltda

Palhoca

BRAZILCAT'S CLAW (UNAD'GATO), (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
7/24/2025HKM Farmacia de Manipulacao Ltda

Palhoca

BRAZILFOLIC ACID (VITAMIN)
75UNAPPROVED
7/24/2025HKM Farmacia de Manipulacao Ltda

Palhoca

BRAZILLEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
7/24/2025SYSTOPIC LABORATORIES PVT LTD

New Delhi

INDIAFLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
7/24/2025SUN PHARMA INDUSTRIES LIMITED

Ranipool

INDIALOTEPREDNOL ETABONATE (ANTI-INFLAMMATORY)
75UNAPPROVED
7/24/2025MANKIND PHARMA LTD PHARMA FORCE

Himachal

INDIAL-CARNITINE (PROTEIN)
75UNAPPROVED
7/24/2025Mankind Pharma Ltd.

New Delhi

INDIAPANTOPRAZOLE SODIUM
75UNAPPROVED
7/24/2025Mankind Pharma Ltd.

New Delhi

INDIADAPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
7/24/2025Hegde & Hedege Pahramaceutical

Mumbai

INDIAKETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
7/24/2025Hegde & Hedege Pahramaceutical

Mumbai

INDIALEVOCETIRIZINE DIHYDROCHLORIDE
75UNAPPROVED
7/24/2025GLAXO SMITHKLINE LTD

Mumbai

INDIAALBENDAZOLE (ANTIPARASITIC)
75UNAPPROVED
7/24/2025Centaur Pharmaceuticals

Mumbai

INDIAPHENYLEPHRINE HCL (ADRENERGIC)
75UNAPPROVED
7/24/2025Amrutanjan Health Care Limited

Chengalpattu

INDIALIDOCAINE
75UNAPPROVED
7/24/2025Apotex Corp.

Weston

UNITED STAROSUVASTATIN CALCIUM
75UNAPPROVED
7/24/2025Viatris, Inc.

Canonsburg

UNITED STACARVEDILOL (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
7/24/2025Novartis Pharma AG

Basel

SWITZERLANVALSARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
7/24/2025TOKARSKI & CIA LTDA

Belo Horizonte

BRAZILSPIRONOLACTONE (DIURETIC)
75UNAPPROVED
7/24/2025TOKARSKI & CIA LTDA

Belo Horizonte

BRAZILMINOXIDIL (ANTI-HYPERTENSIVE)
75UNAPPROVED
7/24/2025ARYA VAIDYA PHARMACY (COIMBATORE

Coimbatore

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/24/2025ISHA LIFE PRIVATE

Coimbatore

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/24/2025ISHA LIFE PRIVATE

Coimbatore

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/24/2025Sai Mirra Innopharm Pvt Ltd

Chennai

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/24/2025ISHA LIFE PRIVATE

Coimbatore

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/24/2025L.K. TEE Enterprise Sdn. Bhd

Taman Klang Jaya

MALAYSIACHOCOLATE AND COCOA, N.E.C.
62NEEDS FCE
83NO PROCESS
7/24/2025L.K. TEE Enterprise Sdn. Bhd

Taman Klang Jaya

MALAYSIACHOCOLATE AND COCOA, N.E.C.
62NEEDS FCE
83NO PROCESS
7/24/2025Quanzhou Liangyou Food Co., Ltd.

Guanqian Community

CHINAMELON SEEDS (EDIBLE SEED)
11UNSAFE COL
274COLOR LBLG
7/24/2025PAT SAF

Montreal

CANADAPASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
218LIST INGRE
+3 more
7/24/2025PAT SAF

Montreal

CANADABAKLAVA
11UNSAFE COL
218LIST INGRE
+3 more
7/24/2025Tiger Consumer Brands Pty Ltd

Paarl

SOUTH AFRIMIXED FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C.
11UNSAFE COL
7/24/2025TAI KIM ANH SEAFOOD JOINT STOCK CORPORATIONVIETNAMSHRIMP & PRAWNS, BREADED
9SALMONELLA
7/24/2025TAI KIM ANH SEAFOOD JOINT STOCK CORPORATIONVIETNAMSHRIMP & PRAWNS, BREADED
9SALMONELLA
7/24/2025TAI KIM ANH SEAFOOD JOINT STOCK CORPORATIONVIETNAMSHRIMP & PRAWNS
9SALMONELLA
7/24/2025NICOTECH OU

Harjumaa

ESTONIANICOTINE POUCH
3854TPLKUSSLLB
7/24/2025NICOBROS OU

Tallinn

ESTONIANICOTINE POUCH
3854TPLKUSSLLB
7/24/2025APRES NICOTINE AB

Vetlanda

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
7/24/2025MICROZERO AB

Goteborg

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
7/24/2025MICROZERO AB

Goteborg

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
7/24/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
7/24/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
7/24/2025LIW INNOVATION AB

Hokerum

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
7/24/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3854TPLKUSSLLB
7/24/2025NGP TOBACCO APS

Norager

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
7/24/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
7/24/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
7/24/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
7/24/2025CONSUMER BRANDS INTERNATIONAL S.R.O

Teplice

CZECH REPUNICOTINE POUCH
3854TPLKUSSLLB
7/24/2025CONSUMER BRANDS INTERNATIONAL S.R.O

Teplice

CZECH REPUNICOTINE POUCH
3854TPLKUSSLLB
7/24/2025CONSUMER BRANDS INTERNATIONAL S.R.O

Teplice

CZECH REPUNICOTINE POUCH
3854TPLKUSSLLB

About This Page

This page displays 50 FDA import refusal records from 13 countries. Records on this page involve violations including 75 (UNAPPROVED), 62 (NEEDS FCE), 83 (NO PROCESS), 11 (UNSAFE COL), 274 (COLOR LBLG) and 6 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 388 of 10,077 • Showing records 19,351-19,400 of 503,850 total