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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
5/6/2025BEIJING HOTGEN BIOTECH CO., LTD

Beijing

CHINAOVER-THE-COUNTER COVID-19 ANTIGEN TEST
118NOT LISTED
237NO PMA
+2 more
5/6/2025BEIJING HOTGEN BIOTECH CO., LTD

Beijing

CHINAOVER-THE-COUNTER COVID-19 ANTIGEN TEST
118NOT LISTED
237NO PMA
+2 more
5/6/2025CORDX

Furstenau

GERMANYOVER-THE-COUNTER COVID-19 ANTIGEN TEST
118NOT LISTED
237NO PMA
+2 more
5/6/2025ALTRUAN

Massing

GERMANYOVER-THE-COUNTER COVID-19 ANTIGEN TEST
118NOT LISTED
237NO PMA
+3 more
5/6/2025COSMETIQUE ASIA CORP

Quezon City

PHILIPPINEMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
16DIRECTIONS
+1 more
5/6/2025GUANGZHOU HONGYI LIMITED LIABILITY

Fo Shan

CHINALASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
47NON STD
5/6/2025Konimex Holding Company Ltd.

Skopje

MACEDONIATEA, CAMOMILLE, CHAMOMILE (TEA SUBSTITUTE)
9SALMONELLA
5/6/2025Konimex Holding Company Ltd.

Skopje

MACEDONIATEA, CAMOMILLE, CHAMOMILE (TEA SUBSTITUTE)
9SALMONELLA
5/5/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
5/5/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3851TPLACKFIRM
3854TPLKUSSLLB
5/5/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3851TPLACKFIRM
3854TPLKUSSLLB
5/5/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3851TPLACKFIRM
3854TPLKUSSLLB
5/5/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3851TPLACKFIRM
3854TPLKUSSLLB
5/5/2025THE SNUS FACTPRY

Odeshog

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
5/5/2025THE SNUS FACTPRY

Odeshog

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
5/5/2025THE SNUS FACTPRY

Odeshog

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
5/5/2025THE SNUS FACTPRY

Odeshog

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
5/5/2025THE SNUS FACTPRY

Odeshog

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
5/5/2025WHITE INDUSTRIES AB

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
5/5/2025THE SNUS FACTPRY

Odeshog

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
5/5/2025APR S NICOTINE AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
5/5/2025Luna Corporate

Suchy Las

POLANDNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
5/5/2025Luna Corporate

Suchy Las

POLANDNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
5/5/2025Luna Corporate

Suchy Las

POLANDNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
5/5/2025Luna Corporate

Suchy Las

POLANDNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
5/5/2025Luna Corporate

Suchy Las

POLANDNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
5/5/2025Man Kang, S. A.

Nindiri

NICARAGUASEA CUCUMBER, OTHER AQUATIC SPECIES
2580MFRHACCP
5/5/2025Man Kang, S. A.

Nindiri

NICARAGUASEA CUCUMBER, OTHER AQUATIC SPECIES
2580MFRHACCP
5/5/2025Man Kang, S. A.

Nindiri

NICARAGUASEA CUCUMBER, OTHER AQUATIC SPECIES
2580MFRHACCP
5/5/2025HBL INTL LTD

Keighley

UNITED KINOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
471CSTIC LBLG
5/5/2025THE NUT CASES INC

Mississauga

CANADACANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE)
324NO ENGLISH
482NUTRIT LBL
+1 more
5/5/2025Pablo Francisco Beltran Sanchez

Quito

ECUADORNOVELTY TEAS, N.E.C.
320LACKS FIRM
321LACKS N/C
+4 more
5/5/2025Pablo Francisco Beltran Sanchez

Quito

ECUADORNOVELTY TEAS, N.E.C.
320LACKS FIRM
321LACKS N/C
+4 more
5/5/2025Pablo Francisco Beltran Sanchez

Quito

ECUADORNOVELTY TEAS, N.E.C.
320LACKS FIRM
321LACKS N/C
+4 more
5/5/2025Pablo Francisco Beltran Sanchez

Quito

ECUADORNOVELTY TEAS, N.E.C.
320LACKS FIRM
321LACKS N/C
+4 more
5/5/2025Pablo Francisco Beltran Sanchez

Quito

ECUADORNOVELTY TEAS, N.E.C.
320LACKS FIRM
321LACKS N/C
+4 more
5/5/2025HUONGVIETMART

Ho Chin Minh

VIETNAMTAMARIND, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED
249FILTHY
5/5/2025FRESH SOURCING SA DE CV

San Luis Rio Colorado

MEXICODATES (PIT FRUIT), (PIT FRUIT)
249FILTHY
5/5/2025Weifang Yibao Foodstuff Co., Ltd.

Anqiu City

CHINAGINGER ROOT (ROOT & TUBER VEGETABLE)
249FILTHY
5/5/2025Weifang Yibao Foodstuff Co., Ltd.

Anqiu City

CHINAGINGER ROOT (ROOT & TUBER VEGETABLE)
249FILTHY
5/5/2025Fujian Jiatian Agricultural Development Co., Ltd

Zhangzhou

CHINAFUNGUS, BLACK (CLOUD EARS), BOKEN OR KIBBLED
249FILTHY
5/5/2025Fujian Jiatian Agricultural Development Co., Ltd

Zhangzhou

CHINAFUNGUS, BLACK (CLOUD EARS), BOKEN OR KIBBLED
249FILTHY
5/5/2025Fujian Jiatian Agricultural Development Co.,Ltd.

Zhangzhou

CHINAFUNGUS, BLACK (CLOUD EARS), BOKEN OR KIBBLED
249FILTHY
5/5/2025ADF Foods Limited

Nadiad

INDIABEANS, CORN, AND PEA, N.E.C. (VEGETABLE)
241PESTICIDE
5/5/2025FIS DANISMANLIK A.S.

Izmir

TURKEYRAISINS, DRIED OR PASTE
241PESTICIDE
5/5/2025VERDURAS DE EXPORTACION

Tecpan Guatemala

GUATEMALASUGAR SNAP PEAS
241PESTICIDE
5/5/2025YUKAI

Zhaoqing

CHINAALIGNER, SEQUENTIAL
118NOT LISTED
3280FRNMFGREG
+1 more
5/5/2025GUANGZHOU SHIYI TECHNOLOGY CO.,

Guangzhou

CHINAINTERNAL POLYMERASE CHAIN REACTION CONTROL, NOT ASSAY SPECIFIC
118NOT LISTED
3280FRNMFGREG
+1 more
5/5/2025GUANGZHOU SHIYI TECHNOLOGY CO.,

Guangzhou

CHINACOVID-19 TEST HOME COLLECTION KIT DEVICES
118NOT LISTED
3280FRNMFGREG
+1 more
5/5/2025PLUSLIFE

Guangzhou

CHINACOVID-19 TEST HOME COLLECTION KIT DEVICES
118NOT LISTED
3280FRNMFGREG
+1 more

About This Page

This page displays 50 FDA import refusal records from 16 countries. Records on this page involve violations including 118 (NOT LISTED), 237 (NO PMA), 3280 (FRNMFGREG), 508 (NO 510(K)), 341 (REGISTERED) and 19 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 540 of 10,077 • Showing records 26,951-27,000 of 503,850 total