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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
5/5/2025ALTRUAN

Massing

GERMANYREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
118NOT LISTED
3280FRNMFGREG
+1 more
5/5/2025SHENZHEN TAILHOO TECHNLOGY CO

Shenzhen

CHINASYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
118NOT LISTED
3280FRNMFGREG
+1 more
5/5/2025ZHEJIANG LASHENG TRADING CO LTD

Shaoxing

CHINAFLOSS, DENTAL
118NOT LISTED
3280FRNMFGREG
+1 more
5/5/2025AJU PHARM CO., LTD.

Guro-gu

SOUTH KOREARTHROSCOPE AND ACCESSORIES
118NOT LISTED
3280FRNMFGREG
+1 more
5/5/2025AJU PHARM CO., LTD.

Guro-gu

SOUTH KOREFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
118NOT LISTED
3280FRNMFGREG
+1 more
5/5/2025UNINEED LTD

Glasgow

UNITED KINSTANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
3280FRNMFGREG
+2 more
5/5/2025HONG KONG ZOEY TRADING CO.,LIMITED

Hong Kong

HONG KONGMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
5/5/2025Vitane Pharmaceutical, Inc.

Congers

UNITED STAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
5/5/2025KENYA KATO

Iwate

JAPANMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
5/5/2025DERMAX CO LTD

Shijiazhuang City

CHINAIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
2380NO PMA/PDP
+2 more
5/5/2025WUHAN GIGAA TECHNOLOGY CO LTD

Wuhan

CHINASYSTEM, LASER, PHOTODYNAMIC THERAPY
118NOT LISTED
237NO PMA
+3 more
5/5/2025DERMAX CO LTD

Shijiazhuang City

CHINAIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+2 more
5/5/2025DERMAX CO LTD

Shijiazhuang City

CHINAIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+2 more
5/5/2025IBIZ TREND LIMITED

Kowloon

HONG KONGMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
237NO PMA
+1 more
5/5/2025GUANGZHOU PLUSLIFE BIOTECH CO

Guangzhou

CHINACOVID-19 TEST HOME COLLECTION KIT DEVICES
118NOT LISTED
237NO PMA
+1 more
5/5/2025BROSCARGO INT'L CO., LTD.

Seo

SOUTH KOREMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
237NO PMA
+2 more
5/5/2025Aplicare Products, LLC

Meriden

UNITED STAPAD, ALCOHOL, DEVICE DISINFECTANT
118NOT LISTED
5/5/2025Ningbo Chinmed Technology Co., Ltd.

Ningbo

CHINADRESSING, WOUND, HYDROPHILIC
78STERILITY
5/5/2025Ningbo Chinmed Technology Co., Ltd.

Ningbo

CHINADRESSING, WOUND, HYDROPHILIC
78STERILITY
5/5/2025RESHIP

Surrey

CANADASYRINGE, PISTON
75UNAPPROVED
5/5/2025Novo Nordisk Pharma Ltd

Chiyoda

JAPANSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
5/5/2025JUSDA (TAIWAN) CO LTD

Taoyuan County

TAIWANFENBENDAZOLE (ANTHELMINTIC)
75UNAPPROVED
5/5/2025Lockerroom Marketing Ltd

Delta

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/5/2025KINGDOM ETUMAX BIO SDN BHD

Petaling

MALAYSIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/5/2025BIOCOL PHARMA, LDA

Alcabideche

PORTUGALDIETARY CONVENTIONAL FOODS, N.E.C.
75UNAPPROVED
5/5/2025KREBZ HEALTHCARE PRIVATE LIMITED

Chennai

INDIAOMEGA-3 (FATS AND LIPID SUBSTANCES)
75UNAPPROVED
5/5/2025EASTERN HEALTHCARE

HARIDWAR

INDIAISOTRETINOIN (KERATOLYTIC)
75UNAPPROVED
5/5/2025Zymo Cosmetics

Santej

INDIAVITAMIN, N.E.C.
75UNAPPROVED
5/5/2025LINUX LABORATORIES

TAMIL NADU

INDIADICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
5/5/2025DREAMZ HEALTHCARE

Banglore

INDIAVITAMIN C (ASCORBIC ACID)
75UNAPPROVED
5/5/2025AASSK PHARMACEUTICALS PVT LTD.

Chennai

INDIACHLORPROMAZINE (ANTI-EMETIC/NAUSEANT)
75UNAPPROVED
5/5/2025Cheryl Laboratories Pvt Ltd

Navi Mumbai

INDIAVITAMIN E (TOCOPHEROL)
75UNAPPROVED
5/5/2025VELITE HEALTHCARE

Hambran

INDIANICOTINAMIDE (NIACINAMIDE) (VITAMIN)
75UNAPPROVED
5/5/2025Sundyota Numandis Probioceuticals Pvt. Ltd.

Bavla

INDIACHOLINE (MINERAL)
75UNAPPROVED
5/5/2025GALENICUM HEALTH COLOMBIA SAS

Bogota

COLOMBIAESCITALOPRAM OXALATE
75UNAPPROVED
5/5/2025Mesosystems Sa

Porto

PORTUGALFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
5/5/2025Sokpol Sp. z o.o.

Myszkow

POLANDNONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
5/5/2025Sokpol Sp. z o.o.

Myszkow

POLANDNONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
5/5/2025Sokpol Sp. z o.o.

Myszkow

POLANDNONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
5/5/2025Sokpol Sp. z o.o.

Myszkow

POLANDNONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
5/5/2025Sokpol Sp. z o.o.

Myszkow

POLANDNONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
5/5/2025Sokpol Sp. z o.o.

Myszkow

POLANDNONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
5/5/2025Sokpol Sp. z o.o.

Myszkow

POLANDNONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
5/5/2025Sokpol Sp. z o.o.

Myszkow

POLANDNONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
5/5/2025ARTURO MANUEL ROMANDIA TOYOS

Guaymas

MEXICOTUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
11UNSAFE COL
274COLOR LBLG
5/5/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINETOMATO SAUCE (WITH OTHER INGREDIENTS)
11UNSAFE COL
238UNSAFE ADD
5/5/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINETOMATO SAUCE (WITH OTHER INGREDIENTS)
11UNSAFE COL
238UNSAFE ADD
5/5/2025ZENITH DRINKS PVT LTD

New Delhi

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
11UNSAFE COL
75UNAPPROVED
5/5/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
5/5/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
1...540541542...10077

About This Page

This page displays 50 FDA import refusal records from 17 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 508 (NO 510(K)), 341 (REGISTERED), 336 (INCONSPICU) and 11 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 541 of 10,077 • Showing records 27,001-27,050 of 503,850 total