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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
12/9/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
12/9/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
12/9/2025NICOTOBACCO

Sokolow

POLANDNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/9/2025NICOTOBACCO

Sokolow

POLANDNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/9/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/9/2025YOIK AB

Gemla

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/9/2025YOIK AB

Gemla

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/9/2025YOIK AB

Gemla

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/9/2025YOIK AB

Gemla

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/9/2025HELIX SWEDEN AB

Helsingborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
12/9/2025Parkacre Limited

Gainsborough

UNITED KINFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
3560SUPPL GMP
12/9/2025Tsang Lin Industries Corp.

Taichung

TAIWANYOGURT (PLAIN, FLAVORED OR FRUIT ADDED)
3422UNFIT4FOOD
12/9/2025Tsang Lin Industries Corp.

Taichung

TAIWANYOGURT (PLAIN, FLAVORED OR FRUIT ADDED)
3422UNFIT4FOOD
12/9/2025Unimed Medical Supplies Inc

Shenzhen

CHINAOXIMETER
508NO 510(K)
12/9/2025ORANTECH INC

Shenzhen

CHINAOXIMETER
508NO 510(K)
12/9/2025ZIDADU TRADING

Kibirizi

TANZANIAFISH, N.E.C.
308MFR INSAN
328USUAL NAME
12/9/2025ZIDADU TRADING

Kibirizi

TANZANIAFISH, N.E.C.
308MFR INSAN
12/9/2025Kyongbo Food

Paju

SOUTH KORERICE CAKES
274COLOR LBLG
12/9/2025Diana Candy Company Limited

Arima

TRINIDAD ACANDY WITHOUT CHOCOLATE N.E.C.
274COLOR LBLG
12/9/2025Diana Candy Company Limited

Arima

TRINIDAD ACANDY WITHOUT CHOCOLATE N.E.C.
274COLOR LBLG
12/9/2025Diana Candy Company Limited

Arima

TRINIDAD AFLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
274COLOR LBLG
12/9/2025SHENZHEN BAISHUN TECHNOLOGY CO.,LTD

Shenzhen

CHINAKITCHEN AND TABLEWARE, N.E.C., (FOODWARE, COOKWARE & TABLEWARE)
260FALSE
473LABELING
12/9/2025NACHAL ALAGAPPAN

Chennai

INDIAOTHER BAKERY PRODUCTS, N.E.C.
249FILTHY
12/9/2025NACHAL ALAGAPPAN

Chennai

INDIAOTHER BAKERY PRODUCTS, N.E.C.
249FILTHY
12/9/2025PHAN KHANH NINH

Ho Chi Minh

VIETNAMTAMARIND, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED
249FILTHY
12/9/2025Moctezuma Medjool Gardens

San Luis Rio Colorado

MEXICODATES (PIT FRUIT), (PIT FRUIT)
249FILTHY
12/9/2025SYNTHITE INDUSTRIES PVT LTD

Cochin

INDIAPEPPER, BLACK, GROUND, CRACKED (SPICE)
249FILTHY
12/9/2025Jeverps Manufacturing Corporation

Metro Manila

PHILIPPINERICE STICKS
249FILTHY
12/9/2025Jeverps Manufacturing Corporation

Metro Manila

PHILIPPINERICE STICKS
249FILTHY
12/9/2025Frutas y Hortalizas del Sur S.A.

San Carlos

CHILESTRAWBERRIES (BERRY)
241PESTICIDE
12/9/2025Al Foah Palm Sector Development Co.

Abu Dhabi

UNITED ARADATES (PIT FRUIT), (PIT FRUIT)
241PESTICIDE
12/9/2025Nithilam Foods Private Limited

Thoothukudi

INDIASESAME OIL, REFINED, SINGLE INGREDIENT
241PESTICIDE
12/9/2025Nithilam Foods Private Limited

Thoothukudi

INDIARICE, BASMATI, PROCESSED (PACKAGED)
241PESTICIDE
12/9/2025SAAR ENTERPRISES

Delhi

INDIARICE, BASMATI, PROCESSED (PACKAGED)
241PESTICIDE
12/9/2025SAAR ENTERPRISES

Delhi

INDIARICE, BASMATI, PROCESSED (PACKAGED)
241PESTICIDE
12/9/2025SAAR ENTERPRISES

Delhi

INDIARICE, BASMATI, PROCESSED (PACKAGED)
241PESTICIDE
12/9/2025SAAR ENTERPRISES

Delhi

INDIARICE, BASMATI, PROCESSED (PACKAGED)
241PESTICIDE
12/9/2025ACUVUE OASYS

Tsim Sha Tsui

HONG KONGLENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
3280FRNMFGREG
+1 more
12/9/2025Wellspect HealthCare (Division of DENTSPLY IH AB)

Molndal

SWEDENCATHETER, STRAIGHT
118NOT LISTED
3280FRNMFGREG
+1 more
12/9/2025ALL NATIONS

Sheung Shui

HONG KONGINTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
118NOT LISTED
3280FRNMFGREG
+1 more
12/9/2025AMI LIFESCIENCES PVT LTD

Karakhadi

INDIASITAGLIPTIN PHOSPHATE (ANTI-DIABETIC)
118NOT LISTED
3280FRNMFGREG
+1 more
12/9/2025AMI LIFESCIENCES PVT LTD

Karakhadi

INDIABENZONATATE (ANTI-TUSSIVE/COLD)
118NOT LISTED
3280FRNMFGREG
+1 more
12/9/2025AMI LIFESCIENCES PVT LTD

Karakhadi

INDIATROMETHAMINE (ALKALIZER)
118NOT LISTED
3280FRNMFGREG
+1 more
12/9/2025AMI LIFESCIENCES PVT LTD

Karakhadi

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
12/9/2025AMI LIFESCIENCES PVT LTD

Karakhadi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
12/9/2025AMI LIFESCIENCES PVT LTD

Karakhadi

INDIAANTI-DIABETIC N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
12/9/2025AMI LIFESCIENCES PVT LTD

Karakhadi

INDIAMUCOLYTIC N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
12/9/2025AMI LIFESCIENCES PVT LTD

Karakhadi

INDIAANTI-EMETIC/NAUSEANT N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
12/9/2025AMI LIFESCIENCES PVT LTD

Karakhadi

INDIAFENOFIBRATE (ANTI-CHOLESTEREMIC)
118NOT LISTED
3280FRNMFGREG
+1 more
12/9/2025AMI LIFESCIENCES PVT LTD

Karakhadi

INDIAANTI-HYPERTENSIVE N.E.C.
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 3842 (TP NO PMTA), 3843 (TP NO SE), 3560 (SUPPL GMP), 3422 (UNFIT4FOOD), 508 (NO 510(K)) and 10 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 29 of 10,038 • Showing records 1,401-1,450 of 501,854 total