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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
11/13/2025Qingdao Blue Gate Food Co.,Ltd

Qingdao

CHINABUTTER/BUTTER FLAVORED,PLAIN COOKIES,BISCUITS AND WAFERS
3421MELAMINE
11/13/2025Qingdao Blue Gate Food Co.,Ltd

Qingdao

CHINABUTTER/BUTTER FLAVORED,PLAIN COOKIES,BISCUITS AND WAFERS
3421MELAMINE
11/13/2025Qingdao Blue Gate Food Co.,Ltd

Qingdao

CHINABUTTER/BUTTER FLAVORED,PLAIN COOKIES,BISCUITS AND WAFERS
3421MELAMINE
11/13/2025Qingdao Blue Gate Food Co.,Ltd

Qingdao

CHINABUTTER/BUTTER FLAVORED,PLAIN COOKIES,BISCUITS AND WAFERS
3421MELAMINE
11/13/2025Qingdao Blue Gate Food Co.,Ltd

Qingdao

CHINABUTTER/BUTTER FLAVORED,PLAIN COOKIES,BISCUITS AND WAFERS
3421MELAMINE
11/13/2025Qingdao Blue Gate Food Co.,Ltd

Qingdao

CHINABUTTER/BUTTER FLAVORED,PLAIN COOKIES,BISCUITS AND WAFERS
3421MELAMINE
11/13/2025Qingdao Blue Gate Food Co.,Ltd

Qingdao

CHINABUTTER/BUTTER FLAVORED,PLAIN COOKIES,BISCUITS AND WAFERS
3421MELAMINE
11/13/2025Qingdao Blue Gate Food Co.,Ltd

Qingdao

CHINABUTTER/BUTTER FLAVORED,PLAIN COOKIES,BISCUITS AND WAFERS
3421MELAMINE
11/13/2025DUKSAN PURE CHEMICALS CO., LTD.

Ansan

SOUTH KOREMISCELLANEOUS PATENT MEDICINES, ETC.
3280FRNMFGREG
333LACKS FIRM
+2 more
11/13/2025Q-Med AB

Uppsala

SWEDENIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
3280FRNMFGREG
11/13/2025Gallant Dachan Seafood Co., Ltd.

Quang Ngai

VIETNAMSHRIMP & PRAWNS, BREADED
2860VETDRUGRES
3220NITROFURAN
11/13/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINEBANANA SAUCE
482NUTRIT LBL
11/13/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINEBANANA SAUCE
482NUTRIT LBL
11/13/2025INDUSTRIAS LOJANA DE ESPECERIASC.A.

Loja

ECUADORMIXED SPICE AND SEASONINGS, GROUND, CRACKED, WITHOUT SALT, N.E.C.
328USUAL NAME
482NUTRIT LBL
+2 more
11/13/2025AESTHETIC EXTRA L

Northampton

UNITED KINHYDROXOCOBALAMIN (VITAMIN)
256INCONSPICU
324NO ENGLISH
+1 more
11/13/2025VIJAYA BALAN

Periyar

INDIATAMARIND (SUBTROPICAL AND TROPICAL FRUIT)
249FILTHY
11/13/2025MIGUEL ANGEL PENA CAMANO

Tulcingo De Valle

MEXICOPEPPER, HOT, DRIED OR PASTE
249FILTHY
11/13/2025EDILBERTO AGUILAR BRUNO

Pueblo Tezonteopan De Bonilla

MEXICOPEPPER, HOT, DRIED OR PASTE
249FILTHY
11/13/2025CAPITAL FOODS PRIVATE LIMITED

Bhilad

INDIASPICES AND SEASONING, GROUND, CRACKED, WITH SALT, N.E.C.
249FILTHY
11/13/2025PAKIL AWAL, S.A.

Chimaltenango

GUATEMALABROCCOLI (LEAF & STEM VEGETABLE)
241PESTICIDE
11/13/2025MATCO FOODS LIMITED

Faisalabad

PAKISTANRICE, BASMATI, PROCESSED (PACKAGED)
241PESTICIDE
11/13/2025Indo Nissin Foods Private Limited

Rewari

INDIANOODLES AND NOODLE PRODUCTS, N.E.C.
218LIST INGRE
321LACKS N/C
+2 more
11/13/2025INDUSTRIAS LOJANA DE ESPECERIASC.A.

Loja

ECUADORMIXED SPICE AND SEASONINGS, GROUND, CRACKED, WITHOUT SALT, N.E.C.
218LIST INGRE
320LACKS FIRM
+1 more
11/13/2025Beiersdorf AG

Hamburg

GERMANYBATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
198COLOR LBLG
11/13/2025BEICHEN YAN

Beijing

CHINAFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
197COSM COLOR
75UNAPPROVED
11/13/2025Ktr Europe Gmbh

Eschborn

GERMANYNEEDLE, ACUPUNCTURE, SINGLE USE
118NOT LISTED
3280FRNMFGREG
+3 more
11/13/2025Paritec Gmbh

Weilheim i. OB

GERMANYNEBULIZER (DIRECT PATIENT INTERFACE)
118NOT LISTED
3280FRNMFGREG
+1 more
11/13/2025Paritec Gmbh

Weilheim i. OB

GERMANYNEBULIZER (DIRECT PATIENT INTERFACE)
118NOT LISTED
3280FRNMFGREG
+1 more
11/13/2025Paritec Gmbh

Weilheim i. OB

GERMANYNEBULIZER (DIRECT PATIENT INTERFACE)
118NOT LISTED
3280FRNMFGREG
+1 more
11/12/20253M Espe Dental Products

Saint Paul

UNITED STAMATERIAL, TOOTH SHADE, RESIN
118NOT LISTED
3280FRNMFGREG
11/12/20253M Espe Dental Products

Saint Paul

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

Saint Paul

UNITED STACEMENT, DENTAL
118NOT LISTED
3280FRNMFGREG
11/12/20253M Espe Dental Products

Saint Paul

UNITED STASEALANT, PIT AND FISSURE, AND CONDITIONER
118NOT LISTED
3280FRNMFGREG
11/12/2025ALTRUAN GMBH

Massing

GERMANYRESEARCH USE ONLY/MICROBIOLOGY
118NOT LISTED
3280FRNMFGREG
11/12/2025CGBIO CO

Gyeonggi-Do

SOUTH KOREFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
118NOT LISTED
3260NO ENGLISH
+2 more
11/12/2025Unicharm Corp

Higashishirakawa-gun

JAPANTAMPON, MENSTRUAL, UNSCENTED
118NOT LISTED
341REGISTERED
11/12/2025HOA NAM PHARMA

Ha Noi

VIETNAMMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
333LACKS FIRM
+2 more
11/12/2025ALLERGAN

Annecy

FRANCEOTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
237NO PMA
+2 more
11/12/2025Caregen Co., Ltd.

Gunpo

SOUTH KOREOTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
237NO PMA
+2 more
11/12/2025H. Lundbeck A/S

Valby

DENMARKESCITALOPRAM OXALATE
118NOT LISTED
11/12/2025Dom Duarte - Industria de Productos Alimentares, Lda

Maia

PORTUGALBARBECUE SAUCE
83NO PROCESS
11/12/2025TAGI Pharma, Inc.

South Beloit

UNITED STALANSOPRAZOLE (ANTI-SECRETORY)
75UNAPPROVED
11/12/2025TAGI Pharma, Inc.

South Beloit

UNITED STADULOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
11/12/2025TAGI Pharma, Inc.

South Beloit

UNITED STARIVAROXABAN
75UNAPPROVED
11/12/2025TAGI Pharma, Inc.

South Beloit

UNITED STALOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
11/12/2025TAGI Pharma, Inc.

South Beloit

UNITED STAPREGABALIN (ANTI-CONVULSANT)
75UNAPPROVED
11/12/2025TAGI Pharma, Inc.

South Beloit

UNITED STACHLORTHALIDONE (DIURETIC)
75UNAPPROVED
11/12/2025SUN PHARMACEUTICAL (BANGLADESH)

Dhaka

BANGLADESHQUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
11/12/2025HEALING PHARMA INDIA PRIVATE

Mumbai

INDIAIVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
75UNAPPROVED
11/12/2025HEALING PHARMA INDIA PRIVATE

Mumbai

INDIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 18 countries. Records on this page involve violations including 3421 (MELAMINE), 3280 (FRNMFGREG), 333 (LACKS FIRM), 483 (DRUG NAME), 75 (UNAPPROVED) and 23 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 90 of 10,038 • Showing records 4,451-4,500 of 501,854 total