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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
11/20/2025P.T. Nipro Indonesia Jaya

Karawang

INDONESIASET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
118NOT LISTED
508NO 510(K)
11/20/2025P.T. Nipro Indonesia Jaya

Karawang

INDONESIASET, DIALYSIS, SINGLE NEEDLE WITH UNI-DIRECTIONAL PUMP
118NOT LISTED
508NO 510(K)
11/20/2025Micro-Tech (Nanjing) Co., Ltd.

Nanjing

CHINADEVICE, SUTURING, STAPLING, GRAFT, AORTIC
118NOT LISTED
508NO 510(K)
11/20/2025LABORATORIOS KLEIN COSMETICA, SLU

Ripollet

SPAINLUBRICANT, PATIENT
118NOT LISTED
508NO 510(K)
11/20/2025P AND G GUATEMALA

Guatemala City

GUATEMALAACETAMINOPHEN (ANALGESIC)
118NOT LISTED
75UNAPPROVED
11/20/2025PIERSAN CENTROAMERICANA S A

Guatemala City

GUATEMALAIBUPROFEN (ANTI-INFLAMMATORY)
118NOT LISTED
75UNAPPROVED
11/20/2025PIERSAN CENTROAMERICANA S A

Guatemala City

GUATEMALAANTI-INFLAMMATORY N.E.C.
118NOT LISTED
75UNAPPROVED
11/20/2025PIERSAN CENTROAMERICANA S A

Guatemala City

GUATEMALAERGOTAMINE TARTRATE (ANALGESIC)
118NOT LISTED
75UNAPPROVED
11/20/2025Bial Portela & Ca. S.A.

South Mamede Do Coronado

PORTUGALACETAMINOPHEN (ANALGESIC)
118NOT LISTED
75UNAPPROVED
11/20/2025NOVO NORDISK SERV PROF S A DE CV

Polando

MEXICOSEMAGLUTIDE (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
11/20/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
11/20/2025GILEAD SCIENCES IRELAND UC

Cork

IRELANDEMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMERATE (ANTI-VIRAL)
118NOT LISTED
75UNAPPROVED
11/20/2025JUVEDERM

Annecy

FRANCEIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
11/20/2025JUVEDERM

Annecy

FRANCEIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
11/20/2025JUVEDERM

Annecy

FRANCEIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
11/20/2025GALDERMA'S HEADQUARTERS

Zug Switzerland

SPAINIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
11/20/2025Dabur India Limited

Silvassa

INDIACAMPHOR (ANTI-PRURITIC)
118NOT LISTED
11/20/2025IBSA Farmaceutici Italia Srl

Lodi

ITALYIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
117DANGEROUS
473LABELING
+1 more
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARTEMPURA FLOUR MIX
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARBEAN CURD, DRIED (STICKS, SHEETS), (MULTIPLE FOOD SPECIALTIES, SIDE DISHES AND DESSERTS
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARNOODLES AND NOODLE PRODUCTS, N.E.C.
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARCURRY POWDER, WITHOUT SALT
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARBUTTER/BUTTER FLAVORED,COOKIE,BISCUIT,WAFER DOUGH
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARMIXED CEREAL, QUICK OR INSTANT COOKING
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARTEA, SPICE
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARTEA, SPICE
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARNOODLES AND NOODLE PRODUCTS, N.E.C.
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARTEA, SPICE
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARTEA, SPICE
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARTEMPURA FLOUR MIX
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARTEA, SPICE
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARCURRY POWDER, WITHOUT SALT
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARCAKES, FILLED (OTHER THAN FRUIT OR JELLY)
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARCURRY POWDER, WITHOUT SALT
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARNOODLES AND NOODLE PRODUCTS, N.E.C.
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARTEA, SPICE
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARTEA, SPICE
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARBUTTER/BUTTER FLAVORED,COOKIE,BISCUIT,WAFER DOUGH
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARNOODLES AND NOODLE PRODUCTS, N.E.C.
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARCAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARFLAVORED OR PARTY CRACKERS
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARMUSTARD GREENS (LEAF & STEM VEGETABLE)
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARBUTTER/BUTTER FLAVORED,COOKIE,BISCUIT,WAFER DOUGH
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARTEA, N.E.C.
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARORANGE, DRIED OR PASTE
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARTEA, N.E.C.
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARTEA, N.E.C.
83NO PROCESS
11/19/2025Jellico Food Co, Ltd.

Taichung City

TAIWANSUBTROPICAL/TROPICAL, MIXED, FLAVORED JAMS, JELLIES, PRESERVES, MARMALADES, BUTTERS AND CANDIED
249FILTHY
11/19/2025Jellico Food Co, Ltd.

Taichung City

TAIWANSUBTROPICAL/TROPICAL, MIXED, FLAVORED JAMS, JELLIES, PRESERVES, MARMALADES, BUTTERS AND CANDIED
249FILTHY
11/19/2025Verionica Lucia Vasquez Lopez

Ambato

ECUADORTAMARIND, DRIED OR PASTE
249FILTHY
1...108109110...10077

About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 118 (NOT LISTED), 508 (NO 510(K)), 75 (UNAPPROVED), 117 (DANGEROUS), 473 (LABELING) and 3 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 109 of 10,077 • Showing records 5,401-5,450 of 503,850 total