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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
6/23/2025IFEX GROUP SRL

Mondovi'

ITALYPLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
218LIST INGRE
6/23/2025Shenzhen Microprofit Biotech Co., Ltd.

Shenzhen

CHINAOVER-THE-COUNTER MOLECULAR TEST TO DETECT SARS-COV-2
118NOT LISTED
3280FRNMFGREG
+1 more
6/23/2025Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site)

Nanjing

CHINAADALIMUMAB ASSAY
118NOT LISTED
3280FRNMFGREG
+1 more
6/23/2025BRPHARM

Gangwon-Do

SOUTH KORESKIN FRESHENERS (SKIN CARE PREPARATIONS)
118NOT LISTED
237NO PMA
+2 more
6/23/2025BRPHARM

Gangwon-Do

SOUTH KORESKIN FRESHENERS (SKIN CARE PREPARATIONS)
118NOT LISTED
237NO PMA
+2 more
6/23/2025DERMAX CO LTD

Shijiazhuang City

CHINAIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
6/23/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
6/23/2025SAYEDA SUFIA SUMI

Dhaka

BANGLADESHMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/23/2025Eli Lilly & Company

Indianapolis

UNITED STAEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
6/23/2025MSD PHARMACEUTICAL PVT LTD

Bangalore

INDIAMETFORMIN HCL (ANTI-DIABETIC)
75UNAPPROVED
6/23/2025Cosmaceutical Research Lab Inc.

Surrey

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
6/23/2025Jiangmen Dream Works Food Co.,Ltd.

Jiangmen

CHINASAUCES, N.E.C.
11UNSAFE COL
6/23/2025Kava Time PTE Ltd dba The Kava Bulk

Nadi

FIJIKAVA KAVA (HERBAL & BOTANICALS, NOT TEAS)
9SALMONELLA
6/22/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
6/22/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
6/22/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
6/22/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
6/22/2025Swedish Match Ab

Stockholm

SWEDENSNUFF, LIGHT, MILD, OR LOW, DRY
3854TPLKUSSLLB
6/22/2025Johnson & Johnson Vision Care, Inc.

Jacksonville

UNITED STADISINFECTANT, MEDICAL DEVICES
118NOT LISTED
3280FRNMFGREG
+1 more
6/22/2025HONG KONG YAOFENG TRADING LTD

Hongkong

HONG KONGZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN)
118NOT LISTED
3280FRNMFGREG
6/22/2025HONG KONG YAOFENG TRADING LTD

Hongkong

HONG KONGZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN)
118NOT LISTED
3280FRNMFGREG
6/22/2025Dongguan Haiyi Technology Co., Ltd

Dongguan

CHINATITANIUM DIOXIDE (PROTECTANT)
118NOT LISTED
3280FRNMFGREG
6/20/2025ALEMBIC PHARAMACEUTICALS LTD

SOUTH SIKKIM

INDIAAZITHROMYCIN (MACAROLIDES)
118NOT LISTED
75UNAPPROVED
6/20/2025ANHOX HEALTH CARE PVT LTD

Mehsana

INDIAMUPIROCIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC)
118NOT LISTED
75UNAPPROVED
6/20/2025Cipla Ltd

Kolhapur

INDIACIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
118NOT LISTED
75UNAPPROVED
6/20/2025JB Chemicals and Pharmaceuticals Ltd

Mumbai

INDIAREPLENISHER N.E.C.
118NOT LISTED
75UNAPPROVED
6/20/2025Alkem Health Science

Sikkim

INDIACEFIXIME (CEPHALOSPORINS)
118NOT LISTED
75UNAPPROVED
6/20/2025INDOCO REMEDIES LIMITED

Mumbai

INDIADICYCLOMINE HCL (ANTI-CHOLINERGIC)
118NOT LISTED
75UNAPPROVED
6/20/2025Vivimed Labs Ltd

Haridwar

INDIAOXYMETAZOLINE HCL (ADRENERGIC)
118NOT LISTED
75UNAPPROVED
6/20/2025ERIS LIFESCIENCES LTD

Ahmedabad

INDIADIBUCAINE (ANESTHETIC)
118NOT LISTED
75UNAPPROVED
6/20/2025Cipla Ltd

Kolhapur

INDIACETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC)
118NOT LISTED
75UNAPPROVED
6/20/2025DR REDDY'S LABORATORIES

Baddi

INDIAHYDROXYZINE HCL (TRANQUILIZER)
118NOT LISTED
75UNAPPROVED
6/20/2025PHARMA BIOLOGICAL

Jaipur

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
6/20/2025A.H. GEIGER

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/20/2025GUSTAVO PEREZ MAGALLON

Zapopan

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/20/2025GUSTAVO PEREZ MAGALLON

Zapopan

MEXICOACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
6/20/2025Minature Wellness Pvt Ltd

Ahmedabad

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
6/20/2025VASU HEALTHCARE PVT LTD

Vadodara

INDIAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
6/20/2025SKM SIDDHA AND AYURVEDHA COMPANY

Erode

INDIAANTIBIOTIC N.E.C.
75UNAPPROVED
6/20/2025Imis Pharmaceuticals Pvt LTD

Vijaywada

INDIAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
6/20/2025HIMALYA WELLNESS COMPANY

Bengaluru

INDIAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
6/20/2025USV Private Limited

Govandi

INDIAASPIRIN (ANALGESIC)
75UNAPPROVED
6/20/2025MENRIK BIOMERGE PVT LTD

New Delhi

INDIAGLIMEPIRIDE (ANTI-DIABETIC)
75UNAPPROVED
6/20/2025PHARMAROOTS HEALTHCARE

Solan

INDIASITAGLIPTIN PHOSPHATE (ANTI-DIABETIC)
75UNAPPROVED
6/20/2025HUAQING XIAN NATURAL INGREDUENTS

Shaanxi

CHINAMETHYLENE BLUE (ANTIDOTE)
75UNAPPROVED
6/20/2025EXMED PHARMACUETICALS

Valsad

INDIACETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC)
75UNAPPROVED
6/20/2025GLAXOSMITHKLINE PHARMACEUTICALS

Solan

INDIAALBENDAZOLE (ANTIPARASITIC)
75UNAPPROVED
6/20/2025Encure Ethicals Pvt Ltd

Goa

INDIANEOMYCIN (AMINOGLYCOSIDES)
75UNAPPROVED
6/20/2025ENCORE HEALTHCARE PVT LTD

Maharashtra

INDIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
6/20/2025ALKEM HEALTH SCIENCE

Namthang

INDIAPANTOPRAZOLE SODIUM
75UNAPPROVED
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About This Page

This page displays 50 FDA import refusal records from 13 countries. Records on this page involve violations including 218 (LIST INGRE), 118 (NOT LISTED), 3280 (FRNMFGREG), 508 (NO 510(K)), 75 (UNAPPROVED) and 6 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 447 of 10,077 • Showing records 22,301-22,350 of 503,850 total