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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
3/6/2025NIPRO CORP.

Odate

JAPANDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
237NO PMA
3/6/2025NIPRO CORP.

Odate

JAPANSTOPCOCK, I.V. SET
237NO PMA
3/6/2025Naturelle LLC

Ras Al Khaimah

UNITED ARADENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
197COSM COLOR
3/6/2025Welch Allyn Inc (Baxter affiliate)

Milwaukee

UNITED STAELECTROCARDIOGRAPH
118NOT LISTED
3280FRNMFGREG
+1 more
3/6/2025Goodman Co., Ltd

Nagoya

JAPANWIRE, GUIDE, CATHETER
118NOT LISTED
3/6/2025Goodman Co., Ltd

Nagoya

JAPANCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE
118NOT LISTED
3/6/2025JOSE MANUEL OLARTE NAJERA

Heroica Puebla De Zaragoza

MEXICOPYRIMETHAMINE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
3/6/2025ACTIVE SILVER

Reading

UNITED KINMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/6/2025DR HEALTHCARE, S.L.U.

Barcelona

SPAINVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
3/6/2025DR HEALTHCARE, S.L.U.

Barcelona

SPAINVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
3/6/2025INVESTIGACION FARMACEUTICA SA DE

Ciudad De Mexico

MEXICOESTROGEN N.E.C.
75UNAPPROVED
3/6/2025HALEON HEALTHCARE

Pedregal

MEXICOANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
3/6/2025ULTRA LABORATORIOS

Guadalajara

MEXICOANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
3/6/2025THE HIMALAYA DRUG COMPANY

Pradesh

INDIAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
3/6/2025ABBIVIE SRL

Campoverde

ITALYUPADACITINIB (ANTI-RHEUMATIC)
75UNAPPROVED
3/6/2025BIOMEP S.A DE CV

Juarez

MEXICOANTI-CHOLINERGIC, N.E.C.
75UNAPPROVED
3/6/2025LABORATORIOS LIEMONT

Cuajimalpa de Marelos

MEXICOMETRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
3/6/2025BIOMEP S.A DE C.V URBINA

Naucalpan De Ju

MEXICOACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
3/6/2025BRULUAGSA SA DE CV

Atlacomulco

MEXICODICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
3/6/2025FARMACOS CONTINENTALES

Puebla

MEXICOALBENDAZOLE (ANTHELMINTIC)
75UNAPPROVED
3/6/2025Labomar Canada Inc

Pointe-Claire

CANADAFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
3/6/2025Labomar Canada Inc

Pointe-Claire

CANADAFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
3/6/2025Baloglu Gida Tarim Urunleri Akaryakitmotorlu Araclar San Ve

Salihli - Manisa

TURKEYKIDNEY BEAN
62NEEDS FCE
83NO PROCESS
3/6/2025Kunming Aoqun Bio-Tech Co,. Ltd

Kunming

CHINAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
274COLOR LBLG
3/6/2025Kunming Aoqun Bio-Tech Co,. Ltd

Kunming

CHINAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
274COLOR LBLG
3/6/2025Gwalia Sweets Pvt Ltd

Ahmedabad

INDIAMULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
11UNSAFE COL
274COLOR LBLG
3/6/2025Kunming Aoqun Bio-Tech Co,. Ltd

Kunming

CHINAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
274COLOR LBLG
3/6/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
3/6/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
3/6/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
3/5/2025TROPICANA FRUITS FARMS INC.

Managua

NICARAGUACORN, BOLTED MEAL OR FLOUR
324NO ENGLISH
3/5/2025BANYENZAKO FISH EXPORT

Dar Es Salaam

TANZANIAEEL
308MFR INSAN
3/5/2025KABAGE ENTERPRISES

Kigoma

TANZANIAFISH, N.E.C.
306INSANITARY
320LACKS FIRM
3/5/2025DONGGANG YIXING FOOD CO.,LTD

Dandong

CHINACLAMS
251POISONOUS
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
3/5/2025Rupsha Fish Private Limited

Kolkata

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA

About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 237 (NO PMA), 197 (COSM COLOR), 118 (NOT LISTED), 3280 (FRNMFGREG), 508 (NO 510(K)) and 12 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 645 of 10,077 • Showing records 32,201-32,250 of 503,850 total