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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
10/7/2025BLUE SAIL MEDICAL CO LTD

Zibo

CHINASURGEON'S GLOVES
118NOT LISTED
3280FRNMFGREG
+1 more
10/7/2025BLUE SAIL MEDICAL CO LTD

Zibo

CHINASURGEON'S GLOVES
118NOT LISTED
3280FRNMFGREG
+1 more
10/7/2025VISHAL SURGICAL CO

Mumbai

INDIASYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
118NOT LISTED
3280FRNMFGREG
+1 more
10/7/2025VISHAL SURGICAL CO

Mumbai

INDIASYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
118NOT LISTED
3280FRNMFGREG
+1 more
10/7/2025PAULINA RIQUIAC

Guatemala

GUATEMALAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
10/7/2025PURE CLEANSE (BIOMIQ.HEALTH)

Kitchener

CANADAIRRIGATION SOLUTION N.E.C.
118NOT LISTED
3280FRNMFGREG
10/7/2025Nakanishi Optical Products Corp.

Osaka

JAPANFRAME, SPECTACLE
118NOT LISTED
3280FRNMFGREG
10/7/2025GOPOP HK LIMITED

Dubai

UNITED ARALENS, CONTACT (DISPOSABLE)
118NOT LISTED
237NO PMA
+1 more
10/7/2025GOPOP HK LIMITED

Dubai

UNITED ARALENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
118NOT LISTED
237NO PMA
+1 more
10/7/2025Nakanishi Optical Products Corp.

Osaka

JAPANSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
+1 more
10/7/2025COCOONCENTER

La Veuve

FRANCEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
10/7/2025COCOONCENTER

La Veuve

FRANCEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
10/7/2025NIPRO INDIA CORPORATION PVT.LTD.

Khandala

INDIADIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
118NOT LISTED
10/7/2025COSMAX, INC.

Hwaseong-si

SOUTH KOREULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
10/7/2025BC LTD C/O PASTURE

Singapore

SINGAPOREPRAVASTATIN SODIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
10/7/2025BC LTD C/O PASTURE

Singapore

SINGAPOREAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
10/7/2025BC LTD C/O PASTURE

Singapore

SINGAPOREAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
10/7/2025BC LTD C/O PASTURE

Singapore

SINGAPOREAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
10/7/2025UJALA HOUSE

Mumbai

INDIABATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
10/7/2025Hamdard Laboratories

Ghazibad

INDIAOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
10/7/2025BULLION GO-NEAT GLOBAL LTD

Ibafo

NIGERIAVITAMIN, N.E.C.
75UNAPPROVED
10/7/2025ARISTOPHARMA LIMITED

Dhaka

BANGLADESHCLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
10/7/2025ESKAYEF PHARMACEUTICALS LTD

Dhaka

BANGLADESHMONTELUKAST SODIUM (ANTI-ASTHMATIC)
75UNAPPROVED
10/7/2025Incepta Pharmaceuticals Ltd

Dhaka

BANGLADESHANTI-HISTAMINIC N.E.C.
75UNAPPROVED
10/7/2025ABDI IBRAHIM ILAC SANAYI VE TICA

Instabul

TURKEYANTIFUNGAL N.E.C.
75UNAPPROVED
10/7/2025Allergan Sales, LLC

Waco

UNITED STABRIMONIDINE TARTRATE (ADRENERGIC)
75UNAPPROVED
10/7/2025Pfizer Manufacturing Belgium NV

Puurs-Sint-Amands

BELGIUMLATANOPROST (PROSTAGLANDIN)
75UNAPPROVED
10/7/2025Eurofarma Laboratorios S.A.

Itapevi

BRAZILSERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
10/7/2025JEEVAN SANJEEVANI HERBS PVT LTD

Mumbai

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
10/7/2025NOVO NORDISK

Gatwick

UNITED KINSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
10/7/2025SUN PHARMACEUTICALS

Pradesh

INDIASTIMULANT N.E.C.
75UNAPPROVED
10/7/2025SUN PHARMACEUTICALS

Pradesh

INDIASTIMULANT N.E.C.
75UNAPPROVED
10/7/2025SUN PHARMACEUTICALS

Pradesh

INDIAVENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
10/7/2025DIABETES CARE CENTRE

Prayagraj

INDIAMETFORMIN HCL (ANTI-DIABETIC)
75UNAPPROVED
10/7/2025CADILA PHARMACEUTICALS LTD

Ahmedabad

INDIAFAMOTIDINE (ANTACID)
75UNAPPROVED
10/7/2025WIN MEDICARE PHARMACEUTICALS

Hyderabad

INDIADICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
10/7/2025NEM LABORATORIES PVT LTD

Maharashtra

INDIAKETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
10/7/2025CIPLA

MUMBAI

INDIAPOVIDONE IODINE (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
10/7/2025Cipla

Kukatpalilly

INDIADICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
10/7/2025Alkem Laboratories Limited

Ankleshwar

INDIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
10/7/2025Fermenta Biotech Limited

Dahej

INDIAVITAMIN D2 (CALCIFEROL)
75UNAPPROVED
10/7/2025SUN PHARMA

Assam

INDIAPANTOPRAZOLE SODIUM
75UNAPPROVED
10/7/2025AYURVEDA PVT LTD

Delhi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/7/2025AYURVEDA PVT LTD

Delhi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/7/2025AYURVEDA PVT LTD

Delhi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/7/2025PROCTOR & GAMBLE

Mumbai

INDIANUTRIENT/TONIC N.E.C.
75UNAPPROVED
10/7/2025Maneesh Pharmaceuticals Limited

Mumbai

INDIAMEDROXYPROGESTERONE ACETATE (PROGESTIN)
75UNAPPROVED
10/7/2025SUN PHARMA

East Sikkum

INDIATRANEXAMIC ACID (HEMOSTATIC)
75UNAPPROVED
10/7/2025WINDLASS BIOTECH

Uttarakhand

INDIANUTRIENT/TONIC N.E.C.
75UNAPPROVED
10/7/2025ATAKAISHNA LIFE SCIENCES

Karnataka

INDIAANTI-DIABETIC N.E.C.
75UNAPPROVED
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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 118 (NOT LISTED), 3280 (FRNMFGREG), 508 (NO 510(K)), 75 (UNAPPROVED), 237 (NO PMA) and 1 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 220 of 10,077 • Showing records 10,951-11,000 of 503,850 total