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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
3/14/2025Oscor Caribe, LLC

Santo Domingo

DOMINICAN CATHETER, STEERABLE
118NOT LISTED
508NO 510(K)
3/14/2025KIM DOMI

Doum 5-Ro

SOUTH KOREMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/14/2025KIM DOMI

Doum 5-Ro

SOUTH KOREMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/14/2025MOHINDER SINGH

Jalandhar

INDIAHOMEOPATHIC DERMATOLOGICAL
75UNAPPROVED
3/14/2025BAILLEUL LABORATOIRES

Luxemburgo

UNITED KINTRETINOIN (KERATOLYTIC)
75UNAPPROVED
3/14/2025BLUE CROSS LABORATORIES PVT LTD

VERNA GOA

INDIADICYCLOMINE HCL (ANTI-CHOLINERGIC)
75UNAPPROVED
3/14/2025ARISTO PHARMACEUTCALS PVT LTD

East Ikkim

INDIAPANTOPRAZOLE SODIUM
75UNAPPROVED
3/14/2025Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)

Daman

INDIAANTI-HYPERTENSIVE N.E.C.
75UNAPPROVED
3/14/2025SM Biomed Sdn Bhd

Sungai Petani

MALAYSIAERYTHROMYCIN (MACROLIDES)
75UNAPPROVED
3/14/2025Alexion Pharma International Operations Unlimited Co.

Dublin 15

IRELANDMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/14/2025APEX LABORATORIES PVT LTD

Chennai

INDIAVITAMIN, N.E.C.
75UNAPPROVED
3/14/2025Franco-Indai

Mumbai

INDIAANALGESIC, N.E.C.
75UNAPPROVED
3/14/2025DR REDDYS LABORATORIES LTD

Solan

INDIAOMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
75UNAPPROVED
3/14/2025Glaxo India

Mumbai

INDIACLAVULANATE POTASS./TICARCILLIN DISODIUM (INHIBITOR (DECARBOXYLASE))
75UNAPPROVED
3/14/2025Glaxo India

Mumbai

INDIALOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
75UNAPPROVED
3/14/2025Centaur Pharmaceuticals

Mumbai

INDIAIMMUNOSUPPRESS N.E.C.
75UNAPPROVED
3/14/2025DR REDDYS LABORATORIES LTD

Solan

INDIAIMMUNOSUPPRESS N.E.C.
75UNAPPROVED
3/14/2025Centaur Pharmaceuticals

Mumbai

INDIASUPPRESSANT N.E.C.
75UNAPPROVED
3/14/2025ALEMBIC PHARMA

Gujarat

INDIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
3/14/2025Alkem Laboratories Ltd

Mumbai

INDIAPANTOPRAZOLE SODIUM
75UNAPPROVED
3/14/2025Glaxo India

Mumbai

INDIAROSUVASTATIN CALCIUM
75UNAPPROVED
3/14/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
3/14/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
3/14/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
3/14/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
3/14/2025Alesayi Beverage Company

Jeddah

SAUDI ARABCARBONATED SOFT DRINK, N.E.C.
11UNSAFE COL
274COLOR LBLG
3/14/2025Unique Fragrances

Sonepat

INDIAFLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
249FILTHY
+1 more
3/14/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+2 more
3/14/2025Central American Fisheries, S.A

Managua

NICARAGUAFISH, N.E.C.
9SALMONELLA
3/14/2025MASHUD AGRO PROCESSING FOOD PRODUCTS LTD.

Chittagong

BANGLADESHBREAD/ROLLS/BUNS, N.E.C.
9SALMONELLA
3/13/2025HALDIRAM SNACKS PVT. LTD.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
9SALMONELLA
3/13/2025Meizhou Jubona Technology Co., Ltd.

Meizhou

CHINAISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
3845DRG REF EI
3/13/2025GILO INTERNATIONAL

London

UNITED KINNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3854TPLKUSSLLB
3/13/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3851TPLACKFIRM
+1 more
3/13/2025MINISTRY A/S

Svendborg

DENMARKNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
+2 more
3/13/2025Swedish Match Ab

Stockholm

SWEDENSNUS
3781TPNOWRNLBL
3842TP NO PMTA
+3 more
3/13/2025Spacelabs Healthcare Gmbh

Nurnberg

GERMANYSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
3280FRNMFGREG
341REGISTERED
3/13/2025Spacelabs Healthcare Gmbh

Nurnberg

GERMANYSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
3280FRNMFGREG
341REGISTERED
3/13/2025Spacelabs Healthcare Gmbh

Nurnberg

GERMANYSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
3280FRNMFGREG
341REGISTERED
3/13/2025Microlife Ag

Widnau

SWITZERLANSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
3280FRNMFGREG
341REGISTERED
3/13/2025Microlife Ag

Widnau

SWITZERLANSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
3280FRNMFGREG
341REGISTERED
3/13/2025Tenwow Food (Group) Co., Ltd

Shanghai

CHINASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
2640CYCLAMATE
3/13/2025SOCIETE DE CONSERVERIE EN AFRIQUE (SCA S.A.)

Dakar

SENEGALTUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
2360HISTAMINE
3/13/2025Medi Glove Co.,Ltd.

Tianjin

CHINAGLOVE, PATIENT EXAMINATION, POLY
477HOLES
3/13/2025Mylan Laboratories Limited

District Dhar

INDIALEVOTHYROXINE SODIUM (THYROID HORMONE)
331DR QUALITC
3/13/2025Pablo Francisco Beltran Sanchez

Quito

ECUADORNOVELTY TEAS, N.E.C.
320LACKS FIRM
321LACKS N/C
+3 more
3/13/2025Pablo Francisco Beltran Sanchez

Quito

ECUADORNOVELTY TEAS, N.E.C.
320LACKS FIRM
321LACKS N/C
+3 more
3/13/2025IT Foods Industries Co Ltd

Muang

THAILANDGOURMAY, GOURAMI
308MFR INSAN
3/13/2025IT Foods Industries Co Ltd

Muang

THAILANDGOURMAY, GOURAMI
308MFR INSAN
3/13/2025IT Foods Industries Co Ltd

Muang

THAILANDGOURMAY, GOURAMI
308MFR INSAN
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About This Page

This page displays 50 FDA import refusal records from 18 countries. Records on this page involve violations including 118 (NOT LISTED), 508 (NO 510(K)), 75 (UNAPPROVED), 11 (UNSAFE COL), 274 (COLOR LBLG) and 22 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 633 of 10,077 • Showing records 31,601-31,650 of 503,850 total