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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
11/21/2025CHAINPOP AB

Goteborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
11/21/2025CHAINPOP AB

Goteborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
11/21/2025CHAINPOP AB

Goteborg

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/21/2025YOIK AB

Gemla

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/21/2025Slowfood Corporation Ltd.

Hadong County

SOUTH KOREPLUM, JUICE, PIT FRUIT JUICES OR CONCENTRATES
3621JUICEHACCP
11/21/2025Parkacre Limited

Gainsborough

UNITED KINMEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
3560SUPPL GMP
11/21/2025ADVANIER LDA

Santo Antonio Da Charneca

PORTUGALLENS, CONTACT (DISPOSABLE)
508NO 510(K)
11/21/2025Novartis Pharma Gmbh

Nuremberg

GERMANYOMALIZUMAB
336INCONSPICU
472NO ENGLISH
+1 more
11/21/2025Beyoglu Cikolata sanayi Ticaret Anonim Sirketi

Merkez

TURKEYCHOCOLATE CANDY BAR, WITHOUT NUTS AND FRUIT
321LACKS N/C
3300ALLERGEN
+1 more
11/21/2025Amber Koku Kozmetik Gida Sanayi Ve Ticaret Limited Sirketi

Efeler

TURKEYPOMEGRANATE, DRIED OR PASTE
321LACKS N/C
482NUTRIT LBL
+1 more
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, N.E.C.
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARCOFFEE, INSTANT
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

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

Yangon

MYANMARLEMON, JAM, JELLY, PRESERVES, MARMALADE, BUTTER AND CANDIED
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARSHRIMP PASTE, FISHERY PRODUCTS, N.E.C.
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARTURMERIC, GROUND, CRACKED (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

MYANMARSESAME SEED (EDIBLE SEED)
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARSARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARCHILI SEASONING ( CHILI POWDER AND PAPRIKA) LIQUID WITHOUT SALT
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

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

Yangon

MYANMARBEANS, CORN, AND PEA, N.E.C. (VEGETABLE)
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARGARLIC, GROUND, CRACKED (SPICE)
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARPEANUT OIL, REFINED, SINGLE INGREDIENT
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARLEAF & STEM VEGETABLES, N.E.C.
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARLEAF & STEM VEGETABLES, N.E.C.
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARLEAF & STEM VEGETABLES, N.E.C.
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARSHRIMP PASTE, FISHERY PRODUCTS, N.E.C.
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

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

Yangon

MYANMARONION, GROUND, CRACKED (SPICE)
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARBEANS, CORN, AND PEA, N.E.C. (VEGETABLE)
83NO PROCESS
11/20/2025Shwe Hinthar Yeik Mon Co., Ltd

Yangon

MYANMARSUGAR PRODUCTS, N.E.C.
83NO PROCESS
11/20/2025EFRAIN EL ANGEL NICOLAS

Actopan

MEXICOSULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
11/20/2025EFRAIN EL ANGEL NICOLAS

Actopan

MEXICOCANAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
11/20/2025Intas Pharmaceuticals Limited

Moraiya

INDIATRANQUILIZER (ANTI-PSYCHOTIC) - PART II N.E.C.
75UNAPPROVED
11/20/2025SUN PHARMA LABORATORIES LIMITED

Gangtok

INDIAANTI-CONVULSANT, N.E.C.
75UNAPPROVED
11/20/2025SHP LABORATORIES LTD

Kamrup

INDIAOLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II
75UNAPPROVED
11/20/2025PHARMACEUTICALS AND MEDICAL DEVI

New Delhi

INDIATRANQUILIZER (ANTI-PSYCHOTIC) - PART II N.E.C.
75UNAPPROVED
11/20/2025LAMFER LABORATORIES

Guatemala

GUATEMALAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
11/20/2025LAMFER LABORATORIES

Guatemala

GUATEMALAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
11/20/2025LAMFER LABORATORIES

Guatemala

GUATEMALADIPHENHYDRAMINE HCL (ANTI-HISTAMINIC)
75UNAPPROVED
11/20/2025LAMFER LABORATORIES

Guatemala

GUATEMALASODIUM (MINERAL)
75UNAPPROVED
11/20/2025LAMFER LABORATORIES

Guatemala

GUATEMALAESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)
75UNAPPROVED
11/20/2025LAMFER LABORATORIES

Guatemala

GUATEMALAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
11/20/2025LAMFER LABORATORIES

Guatemala

GUATEMALAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
11/20/2025LAMFER LABORATORIES

Guatemala

GUATEMALAANTACID, N.E.C.
75UNAPPROVED
11/20/2025LAMFER LABORATORIES

Guatemala

GUATEMALAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 10 countries. Records on this page involve violations including 3842 (TP NO PMTA), 3621 (JUICEHACCP), 3560 (SUPPL GMP), 508 (NO 510(K)), 336 (INCONSPICU) and 6 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 106 of 10,077 • Showing records 5,251-5,300 of 503,850 total