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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
11/12/2025DMG Chemisch Pharmazeutische Fabrik GmbH

Hamburg

GERMANYCROWN AND BRIDGE, TEMPORARY, RESIN
118NOT LISTED
3280FRNMFGREG
11/12/2025KURARAY NORITAKE DENTAL NIIGATA PLANT

Tainai

JAPANAGENT, TOOTH BONDING, RESIN
118NOT LISTED
3280FRNMFGREG
11/12/20253M Espe Dental Products

Saint Paul

UNITED STAMATERIAL, IMPRESSION
118NOT LISTED
3280FRNMFGREG
11/10/2025PRIME CARE AG

Rumlang

SWITZERLANSOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE
118NOT LISTED
3280FRNMFGREG
11/10/2025BEIJING PEFECTLASER TECHNOLGY

Beijing

CHINAMASSAGER, VACCUUM, LIGHT INDUCED HEATING
118NOT LISTED
3280FRNMFGREG
11/10/2025Interojo Inc.

Pyeongtaek City

SOUTH KORELENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
3280FRNMFGREG
11/10/2025DNA Genotek Inc.

Kanata

CANADADNA SPECIMEN COLLECTION, SALIVA
118NOT LISTED
341REGISTERED
11/10/2025BUCKINGHAM HEALTHCARE LTD

Kings Lynn

UNITED KINDRESSING, WOUND, HYDROGEL
118NOT LISTED
341REGISTERED
11/10/2025SPARK HOLLAND

Emmen

NETHERLANDSYRINGE, PISTON
118NOT LISTED
341REGISTERED
11/10/2025SHIPPING FACILITY

Saltillo

MEXICOSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
+2 more
11/10/2025SANDEEP KAUR

Amritsar

INDIASPECTACLE, MAGNIFYING
118NOT LISTED
235NOT IMPACT
+1 more
11/10/2025PANTOS

Wuxi

CHINASUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
+1 more
11/10/2025Sanofi Aventis

Altfortville

FRANCEIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+2 more
11/10/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
118NOT LISTED
11/10/2025SOUKARE

Dubai

UNITED ARALENS, CONTACT (DISPOSABLE)
118NOT LISTED
11/10/2025Melaleuca Inc

Idaho Falls

UNITED STAWHITE LOTION ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
11/10/2025Alcon Canada Inc

Mississauga

CANADALENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
11/10/2025Procter & Gamble Manufacturing Mexico, S. de R.L. de C.V.

Naucalpan

MEXICOBISMUTH (ANTACID)
118NOT LISTED
11/10/2025PROVITA NUTRITION AND HEALTH INC

Port Coquitlam

CANADAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
11/10/2025VENTURE LIFE LTD

Bracknell

UNITED KINDEXTROSE (NUTRIENT/TONIC)
75UNAPPROVED
11/10/2025Novo Nordisk A/S

Bagsvard

DENMARKINSULIN (INJ) (ANTI-DIABETIC)
75UNAPPROVED
11/10/2025Novo Nordisk A/S

Bagsvard

DENMARKINSULIN (INJ) (ANTI-DIABETIC)
75UNAPPROVED
11/10/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREPASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KORECLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREMOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREPASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREMOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025AbbVie Inc.

North Chicago

UNITED STAONABOTULINUMTOXINA
75UNAPPROVED
11/10/2025BC LTD C/O PASTURE

Singapore

SINGAPORERIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
75UNAPPROVED
11/10/2025NIRVAIR SINGH

Assandh

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
11/10/2025UNKNOWN MANUFACTURET

UNKNOWN

CANADAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
11/10/2025CONSUMER HEALTHCARE GSK

Philadelphia

UNITED STAAZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC)
75UNAPPROVED
11/10/2025COCOONCENTER

La Veuve

FRANCEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
11/10/2025Medytox Inc.

Cheongju

SOUTH KOREONABOTULINUMTOXINA
75UNAPPROVED
11/10/2025KUNAL PATEL

Napad Talpad

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
11/10/2025GLAXO SMITH KLINE

London

UNITED KINFLUTICASONE PROPIONATE (BRONCHODILATOR)
75UNAPPROVED
11/10/2025COSMAX, INC.

Hwaseong-si

SOUTH KOREOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
11/10/2025Pfizer Ireland Pharmaceuticals

Dublin 14

IRELANDAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
11/10/2025KOREA STAR

Incheon

SOUTH KOREACYCLOVIR (ANTI-VIRAL)
75UNAPPROVED
11/10/2025E11EMENT INC.

Scarborough

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
11/10/2025E11EMENT INC.

Scarborough

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
11/10/2025E11EMENT INC.

Scarborough

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
11/10/2025RTS Cosmetic Co., Ltd.

Namdong-gu

SOUTH KOREOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
11/10/2025COSMAX, INC.

Hwaseong-si

SOUTH KOREOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
11/10/2025RTS Cosmetic Co., Ltd.

Namdong-gu

SOUTH KOREOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
11/10/2025COSMAX, INC.

Hwaseong-si

SOUTH KOREFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025OLCARE LABORATORIES

Wadhwancty

INDIAVITAMIN B6 (PYRIDOXINE)
75UNAPPROVED
11/10/2025GLENMARK PHARMACEUTICAL

Baddi

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
11/10/2025CORONO REMEDIES PVT

Gujrat

INDIAROSUVASTATIN CALCIUM
75UNAPPROVED
11/10/2025OLCARE LABORATORIES

Wadhwancty

INDIALINAGLIPTIN (ANTI-DIABETIC)
75UNAPPROVED
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About This Page

This page displays 50 FDA import refusal records from 16 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 341 (REGISTERED), 235 (NOT IMPACT), 237 (NO PMA) and 2 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 134 of 10,077 • Showing records 6,651-6,700 of 503,850 total