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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
9/24/2025Tsang Lin Industries Corp.

Taichung

TAIWANMIXED FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C.
3422UNFIT4FOOD
9/24/2025Tsang Lin Industries Corp.

Taichung

TAIWANMIXED FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C.
3422UNFIT4FOOD
9/24/2025Tsang Lin Industries Corp.

Taichung

TAIWANMIXED FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C.
3422UNFIT4FOOD
9/24/2025Tsang Lin Industries Corp.

Taichung

TAIWANMIXED FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C.
3422UNFIT4FOOD
9/24/2025Tianjin Ranova Petfood Co., Ltd.

Jinghai Economic

CHINAPET CAT FOOD N.E.C.
3421MELAMINE
3422UNFIT4FOOD
+1 more
9/24/2025C&G International Gift Manufacture Co. Ltd.

Qingdao

CHINACHOCOLATE AND COCOA PRODUCTS, N.E.C.
3421MELAMINE
9/24/2025RUSABI

Bengaluru

INDIATOOTHBRUSH, MANUAL
3280FRNMFGREG
9/24/2025FARMAMEDICA SA

Guatemala

GUATEMALASYRINGE, PISTON
3280FRNMFGREG
9/24/2025PT. PABRIK LAMONGAN BMI

Lamongan

INDONESIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
3220NITROFURAN
9/24/2025Foshan Runlin Trading Co., Ltd

Foshan

CHINASHRIMP & PRAWNS
2860VETDRUGRES
9/24/2025Hipp GmbH & CO Vertrieb KG

Pfaffenhofen A.d.ilm

GERMANYMILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA
2160LACK NOTIF
256INCONSPICU
+3 more
9/24/2025SWEETCARE LDA

Porto

PORTUGALCONDOM
508NO 510(K)
9/24/2025Shenzhen Microprofit Biotech Co., Ltd.

Shenzhen

CHINARESPIRATORY SPECIMEN NUCLEIC ACID SARS-COV-2 TEST
508NO 510(K)
9/24/2025Shenzhen Microprofit Biotech Co., Ltd.

Shenzhen

CHINACONTAINER, SPECIMEN
508NO 510(K)
9/24/2025Shenzhen Microprofit Biotech Co., Ltd.

Shenzhen

CHINADEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
508NO 510(K)
9/24/2025Shenzhen Microprofit Biotech Co., Ltd.

Shenzhen

CHINADEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
508NO 510(K)
9/24/2025Shenzhen Microprofit Biotech Co., Ltd.

Shenzhen

CHINADEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
508NO 510(K)
9/24/2025Altek Biotechnology Corporation/ Altek (Kunshan) Corp Ltd

Kunshan

CHINASYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
508NO 510(K)
9/24/2025Altek Biotechnology Corporation/ Altek (Kunshan) Corp Ltd

Kunshan

CHINASYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
508NO 510(K)
9/24/2025Altek Biotechnology Corporation/ Altek (Kunshan) Corp Ltd

Kunshan

CHINASYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
508NO 510(K)
9/24/2025Altek Biotechnology Corporation/ Altek (Kunshan) Corp Ltd

Kunshan

CHINASYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
508NO 510(K)
9/24/2025Miriam Guadalupe Gamino Diaz

Guadalajara

MEXICOSOFT CANDY WITH COCONUT, N.E.C. (WITHOUT CHOCOLATE)
482NUTRIT LBL
9/23/2025Selectepharma

Mixco

GUATEMALANORFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC)
75UNAPPROVED
9/23/2025Selectepharma

Mixco

GUATEMALAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
9/23/2025Selectepharma

Mixco

GUATEMALAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
9/23/2025Selectepharma

Mixco

GUATEMALAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
9/23/2025Selectepharma

Mixco

GUATEMALAALLOPURINOL (XANTHINE OXIDASE INHIBITOR)
75UNAPPROVED
9/23/2025Infasa

Mixco

GUATEMALADEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD)
75UNAPPROVED
9/23/2025MERCK S A

Mixco

GUATEMALAIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
9/23/2025MERCK S A

Mixco

GUATEMALAESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)
75UNAPPROVED
9/23/2025MERCK S A

Mixco

GUATEMALAIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
9/23/2025MERCK S A

Mixco

GUATEMALAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
9/23/2025BAYER LABORATORY

Guatemala City

GUATEMALAPOLYETHYLENE GLYCOL 3350/ELECTROLYTES (CARTHARTIC)
75UNAPPROVED
9/23/2025MEDWISE OVERSEAS PVT LTD

Ahmedabad Ahmedabad

INDIAACETYLCYSTEINE (MUCOLYTIC)
75UNAPPROVED
9/23/2025MEDWISE OVERSEAS PVT LTD

Ahmedabad Ahmedabad

INDIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
9/23/2025MEDWISE OVERSEAS PVT LTD

Ahmedabad Ahmedabad

INDIAHYDROCORTISONE ACETATE (GLUCOCORTICOID)
75UNAPPROVED
9/23/2025MEDWISE OVERSEAS PVT LTD

Ahmedabad Ahmedabad

INDIAANTIBIOTIC N.E.C.
75UNAPPROVED
9/23/2025MEDWISE OVERSEAS PVT LTD

Ahmedabad Ahmedabad

INDIAZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT)
75UNAPPROVED
9/23/2025MEDWISE OVERSEAS PVT LTD

Ahmedabad Ahmedabad

INDIADIPHENHYDRAMINE HCL (ANTI-HISTAMINIC)
75UNAPPROVED
9/23/2025MEDWISE OVERSEAS PVT LTD

Ahmedabad Ahmedabad

INDIACLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
9/23/2025MEDWISE OVERSEAS PVT LTD

Ahmedabad Ahmedabad

INDIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
9/23/2025MEDWISE OVERSEAS PVT LTD

Ahmedabad Ahmedabad

INDIABACITRACIN ZINC (PEPTIDES)
75UNAPPROVED
9/23/2025MEDWISE OVERSEAS PVT LTD

Ahmedabad Ahmedabad

INDIAASPIRIN (ANALGESIC)
75UNAPPROVED
9/23/2025TECNOQUIMICA

Yumbo

COLOMBIAVITAMIN C (ASCORBIC ACID)
75UNAPPROVED
9/23/2025LABORATORIO FARMACEUTICO EN MEDE

Antioquia

COLOMBIANITAZOXANIDE
75UNAPPROVED
9/23/2025Biochem Farmaceutica De Colombia

Bogota

COLOMBIAOXANTEL PAMOATE (ANTHELMINTIC)
75UNAPPROVED
9/23/2025ROEMMERS COLUMBIA

Bogota

COLOMBIAIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
9/23/2025PANTSON PHARM

Navsari

INDIAPERINDOPRIL ERBUMINE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
9/23/2025TORANT PHARMACEUTICAL LTD

Mehsana

INDIAINDAPAMIDE (DIURETIC)
75UNAPPROVED
9/23/2025PURE AND CURE HEALTHCARE PVT LTD

Haridwar

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 9 countries. Records on this page involve violations including 3422 (UNFIT4FOOD), 3421 (MELAMINE), 3878 (POISONORD), 3280 (FRNMFGREG), 2860 (VETDRUGRES) and 9 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 252 of 10,077 • Showing records 12,551-12,600 of 503,850 total