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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
11/10/2025APRES NICOTINE AB

Vetlanda

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/10/2025APRES NICOTINE AB

Vetlanda

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/10/2025APRES NICOTINE AB

Vetlanda

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/10/2025APRES NICOTINE AB

Vetlanda

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/10/2025APRES NICOTINE AB

Vetlanda

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/10/2025APRES NICOTINE AB

Vetlanda

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/10/2025APRES NICOTINE AB

Vetlanda

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/10/2025APRES NICOTINE AB

Vetlanda

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/10/2025APRES NICOTINE AB

Vetlanda

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/10/2025YOIK AB

Gemla

SWEDENNICOTINE POUCH
3842TP NO PMTA
11/10/2025Parkacre Limited

Gainsborough

UNITED KINWHEY (DRIED
3560SUPPL GMP
11/10/2025K DENTAL SUPPLIES

Incheon

SOUTH KORECEMENT, DENTAL
508NO 510(K)
11/10/2025Asahi Intecc Hanoi Co., Ltd.

Hanoi

VIETNAMCATHETER GUIDE WIRE KIT
508NO 510(K)
11/10/2025Body Clock Health Care Ltd

London

UNITED KINSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
508NO 510(K)
11/10/2025Body Clock Health Care Ltd

London

UNITED KINSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
508NO 510(K)
11/10/2025ANTEPSAN KURUYEMIS GIDA SANAYI VE TICARET ANONIM S

Sehitkamil

TURKEYPISTACHIO, TOPPING
482NUTRIT LBL
11/10/2025XI AN AOGU BIOTECH CO LTD

Xian

CHINANONI (HERBAL & BOTANICALS, NOT TEAS)
473LABELING
75UNAPPROVED
11/10/2025IBTJ CO LTD

Osaka

JAPANOTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
474COSMETLBLG
11/10/2025UCL Co., Ltd

Namdong

SOUTH KORESHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
11/10/2025EJET(HK) TRADING LIMITED

Kwun Tong

HONG KONGSPONGE, GAUZE
341REGISTERED
11/10/2025LABORATORIOS SANTA FE S.A.

Guatemala

GUATEMALAFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
324NO ENGLISH
75UNAPPROVED
11/10/2025QUINFICA LABORATORY

Guatemala

GUATEMALAFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
324NO ENGLISH
75UNAPPROVED
11/10/2025LABORATORY CONAMEP

Guatemala

GUATEMALAFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
324NO ENGLISH
75UNAPPROVED
11/10/2025LAFAGE

Guatemala

GUATEMALAFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
324NO ENGLISH
75UNAPPROVED
11/10/2025Mucos Pharma GmbH & Co. KG

Berlin

GERMANYVITAMIN, N.E.C.
324NO ENGLISH
11/10/2025Prosa Productos Naturales, S.A. de C.V.

Mexico

MEXICOMASCARA (EYE MAKEUP PREPARATIONS)
310POISONOUS
11/10/2025BIOCOL PHARMA, LDA

Alcabideche

PORTUGALFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
260FALSE
11/10/2025LABIALFARMA SA

Ovoa

PORTUGALCHOLINE (MINERAL)
260FALSE
11/10/2025PET WORKSHOP LTD

Riga

LATVIAPET DOG FOOD N.E.C.
256INCONSPICU
11/10/2025ALLAYURVEDA.COM (PVT) LTD

Kolkata

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
251POISONOUS
11/10/2025SINIT SIRIBODHI

Lak Si

THAILANDFISH, N.E.C.
249FILTHY
11/10/2025Licona Cacahuatitla Maria Jannete

Tulancingo

MEXICOTAMARIND, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
249FILTHY
11/10/2025MISS PHICHAWI WORASIRICHAROENTHAWI

Lat Krabang

THAILANDFISH, N.E.C.
249FILTHY
11/10/2025MUNTIMADUGU RAMA MANI

Anantapur Urban

INDIAOTHER BAKERY PRODUCTS, N.E.C.
249FILTHY
11/10/2025MUNTIMADUGU RAMA MANI

Anantapur Urban

INDIATAMARIND (SUBTROPICAL AND TROPICAL FRUIT)
249FILTHY
11/10/2025MISS PHICHAWI WORASIRICHAROENTHAWI

Lat Krabang

THAILANDFISH, N.E.C.
249FILTHY
11/10/2025MISS PHICHAWI WORASIRICHAROENTHAWI

Lat Krabang

THAILANDFISH, N.E.C.
249FILTHY
11/10/2025SWAPNALI SANJAY KH

Panvel

INDIATAMARIND (SUBTROPICAL AND TROPICAL FRUIT)
249FILTHY
11/10/2025YUE SANG TRADING LTD

Chai Wan

HONG KONGMUSHROOMS AND OTHER FUNGI PRODUCTS, BROKEN OR KIBBLED, N.E.C.
249FILTHY
11/10/2025ALEJANDRA TORRES M

Uruapan

MEXICOSOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
11/10/2025DHARAMPAL PREMCHAND LTD

Noida

INDIABETEL NUT, SHELLED
238UNSAFE ADD
11/10/2025NATARAJ OIL MILLS PVT LTD

Madurai

INDIAMUSTARD OIL, CRUDE, SEE 28O FOR MUSTARD OIL AS A FLAVORING
238UNSAFE ADD
11/10/2025NATARAJ OIL MILLS PVT LTD

Madurai

INDIAMUSTARD OIL, CRUDE, SEE 28O FOR MUSTARD OIL AS A FLAVORING
238UNSAFE ADD
11/10/2025NATARAJ OIL MILLS PVT LTD

Madurai

INDIAMUSTARD OIL, CRUDE, SEE 28O FOR MUSTARD OIL AS A FLAVORING
238UNSAFE ADD
11/10/2025GOPOP HK LIMITED

Dubai

UNITED ARALENS, CONTACT (DISPOSABLE)
237NO PMA
11/10/2025LINHAISHI WANDA GLASSES FACTORY

LINHAI

CHINASUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
11/10/2025LINHAISHI WANDA GLASSES FACTORY

LINHAI

CHINASUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
11/10/2025LINHAISHI WANDA GLASSES FACTORY

LINHAI

CHINASUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
11/10/2025LINHAISHI WANDA GLASSES FACTORY

LINHAI

CHINASUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
11/10/2025LINHAISHI WANDA GLASSES FACTORY

LINHAI

CHINASUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
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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 3842 (TP NO PMTA), 3560 (SUPPL GMP), 508 (NO 510(K)), 482 (NUTRIT LBL), 473 (LABELING) and 13 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 98 of 10,038 • Showing records 4,851-4,900 of 501,854 total