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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
6/13/2025Guangzhou Pluslife Biotech Co., Ltd.

Guangzhou

CHINACOVID-19 TEST HOME COLLECTION KIT DEVICES
118NOT LISTED
3280FRNMFGREG
+1 more
6/13/2025HASAKI BEAUTY & CLINIC JSC

Hanoi City

VIETNAMCLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
3280FRNMFGREG
+2 more
6/13/2025HASAKI BEAUTY & CLINIC JSC

Hanoi City

VIETNAMCLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
3280FRNMFGREG
+2 more
6/13/2025Johnson & Johnson Vision Care, Inc.

Jacksonville

UNITED STAACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS
118NOT LISTED
3280FRNMFGREG
+2 more
6/13/2025GALAXO PHARMA

New South Wales

AUSTRALIAADRENOCORTICAL STEROID N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
6/13/2025GALAXO PHARMA

New South Wales

AUSTRALIAADRENOCORTICAL STEROID N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
6/13/2025GALAXO PHARMA

New South Wales

AUSTRALIAADRENOCORTICAL STEROID N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
6/13/2025GALAXO PHARMA

New South Wales

AUSTRALIATESTOSTERONE CYPIONATE (ANDROGEN)
118NOT LISTED
3280FRNMFGREG
+1 more
6/13/2025VEYKA CONSTRUCTION & ENGINEERING

Cankaya

TURKEYFIRST AID KIT WITHOUT DRUG
118NOT LISTED
3280FRNMFGREG
6/13/2025AURORA S COEPIK

Seoul

SOUTH KOREEXTERNAL MECHANICAL STIMULATOR FOR THE RELIEF OF CONGESTION
118NOT LISTED
3280FRNMFGREG
6/13/2025Johnson & Johnson Vision Care, Inc.

Jacksonville

UNITED STAACCESSORIES TO CONTACT LENS SOLUTION
118NOT LISTED
341REGISTERED
+1 more
6/13/2025DENTAL MOLD

Guatemala

GUATEMALADENTURE, PLASTIC, TEETH
75UNAPPROVED
84RX DEVICE
6/13/2025Laboratoire Unither

Coutances

FRANCEMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/13/2025LIVE BIO PHARMA

Kerla

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/13/2025BDR PHARMACEUTICALS

Dehradun

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/13/2025J B CHEMICALS AND PHARMACEUTICAL

South Sikkm

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/13/2025Sun Pharma

Sikkim

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/13/2025FARMAMEDICA SA

Guatemala

GUATEMALAVITAMIN, N.E.C.
75UNAPPROVED
6/13/2025LABORATORIES PHARMA

El Salvador

EL SALVADOCEFIXIME (CEPHALOSPORINS)
75UNAPPROVED
6/13/2025Procaps S.A. de C.V.

Soyapango

EL SALVADOPENICILLIN NATURAL, N.E.C.
75UNAPPROVED
6/13/2025Corporacion Bonima

Ilopango

EL SALVADOPREDNISOLONE (GLUCOCORTICOID)
75UNAPPROVED
6/13/2025LAB PHARMEDIC

Soyapango

EL SALVADOFOLIC ACID (VITAMIN)
75UNAPPROVED
6/13/2025LABORATORIOS LA SANTE SA

Bogota

COLOMBIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
6/13/2025ASHAPURA MINECHEM LTD.

Mumbai

INDIAZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN)
75UNAPPROVED
6/13/2025Rottendorf Pharma Gmbh

Ennigerloh

GERMANYEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
6/13/2025INGENEUS

Mount Waverley

AUSTRALIAGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
476NO REGISTR
6/13/2025OVELAPS PACIFIC LIMITED

Kwai Chung

HONG KONGLASER MARKER OR ENGRAVER
47NON STD
6/13/2025Xinxiang Tuoxin Pharmaceutical Co. Ltd

Xinxiang

CHINAANTIBIOTIC N.E.C.
27DRUG GMPS
6/13/2025ALTERA PUBLICIDAD SA de CV

Ciudad Obregon

MEXICOCANDY WITHOUT CHOCOLATE N.E.C.
11UNSAFE COL
274COLOR LBLG
6/13/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
6/13/2025PEXVARGT S.A.

Guatemala City

GUATEMALACARBONATED SOFT DRINK, N.E.C.
11UNSAFE COL
6/13/2025AGROPECUARIA MALICHITA SA DE CV

Heroica Guaymas

MEXICOCANTALOUPE (VINE FRUIT)
9SALMONELLA
6/12/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
6/12/2025Swedish Match Ab

Stockholm

SWEDENCIGARETTE COMPONENT, PART OR ACCESSORY, NEC
3854TPLKUSSLLB
6/12/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
6/12/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
6/12/2025Swedish Match Ab

Stockholm

DENMARKSNUS
3851TPLACKFIRM
3854TPLKUSSLLB
6/12/2025STRENGBERGS OU

Pietarsaari

FINLANDNICOTINE POUCH
3842TP NO PMTA
3854TPLKUSSLLB
6/12/2025LIW INNOVATION AB

Hokerum

SWEDENNICOTINE POUCH
3842TP NO PMTA
3854TPLKUSSLLB
6/12/2025TRIDOTS UK

London

UNITED KINNICOTINE POUCH
3842TP NO PMTA
3854TPLKUSSLLB
6/12/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
6/12/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
6/12/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
6/12/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
6/12/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
6/12/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
6/12/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
+1 more
6/12/2025ACTIV SP ZOO

Warsaw

POLANDSMOKELESS TOBACCO POUCHES
3842TP NO PMTA
3843TP NO SE
+1 more
6/12/2025Swedish Match Ab

Stockholm

SWEDENSMOKELESS TOBACCO POUCHES
3842TP NO PMTA
3843TP NO SE
+1 more
6/12/202577 POUCHES

Cracow

POLANDNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
1...458459460...10077

About This Page

This page displays 50 FDA import refusal records from 19 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 508 (NO 510(K)), 341 (REGISTERED), 75 (UNAPPROVED) and 11 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 459 of 10,077 • Showing records 22,901-22,950 of 503,850 total