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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
6/11/2025Belmora LLC

Arlington

UNITED STAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
3280FRNMFGREG
6/11/2025Belmora LLC

Arlington

UNITED STAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
3280FRNMFGREG
6/11/2025BIOMIN TECHNOLOGIES LTD

Stoke-On-Trent

UNITED KINSTANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
3280FRNMFGREG
6/11/2025ALTRUAN GMBH

Massing

GERMANYGENERAL PURPOSE REAGENT
118NOT LISTED
2380NO PMA/PDP
+1 more
6/11/2025Pharmascience Inc

Severn

UNITED STAMATERIAL, IMPRESSION
118NOT LISTED
341REGISTERED
6/11/2025Pharmascience Inc

Severn

UNITED STAMATERIAL, IMPRESSION
118NOT LISTED
341REGISTERED
6/11/2025Pharmascience Inc

Severn

UNITED STAMATERIAL, IMPRESSION
118NOT LISTED
341REGISTERED
6/11/2025GUANGZHOU SHIYI TECHNOLOGY CO.,

Guangzhou

CHINAOVER-THE-COUNTER COVID-19 ANTIGEN TEST
118NOT LISTED
237NO PMA
+1 more
6/11/2025Agni Exim Private Limited

Nayabasti

NEPALNATURAL EXTRACT OR FLAVOR, N.E.C.
83NO PROCESS
6/11/2025Agni Exim Private Limited

Nayabasti

NEPALPASTES, N.E.C.
83NO PROCESS
6/11/2025Agni Exim Private Limited

Nayabasti

NEPALNATURAL EXTRACT OR FLAVOR, N.E.C.
83NO PROCESS
6/11/2025Twelve summers (Xiamen) Food Technology Co., Ltd.

Xiamen

CHINAGELATIN, N.E.C.
83NO PROCESS
6/11/2025Twelve summers (Xiamen) Food Technology Co., Ltd.

Xiamen

CHINAGELATIN, N.E.C.
83NO PROCESS
6/11/2025PLANTAS MEDICINALES

Temecula

UNITED STAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
6/11/2025ZEELAB PHARMACY PVT LTD

New Delhi

INDIAAMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
6/11/2025J VEERARAJU

Eluru

INDIAPANTOPRAZOLE SODIUM
75UNAPPROVED
6/11/2025ALAN BERMAN

Gampaha District

SRI LANKAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/11/2025Vicco Laboratories

Panaji Goa

INDIADENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
6/11/2025GLAXOSMITHKLINE PHARMACEUTICAL L

NASIK

INDIABETAMETHASONE DIPROPIONATE (GLUCOCORTICOID)
75UNAPPROVED
6/11/2025Gillette Diversified Operations Private Limited

Ahmedabad

INDIACAMPHOR (ANTI-PRURITIC)
75UNAPPROVED
6/11/2025Gillette Diversified Operations Private Limited

Ahmedabad

INDIACAMPHOR (ANTI-PRURITIC)
75UNAPPROVED
6/11/2025Accra Pac (India) Pvt Ltd

Vapi

INDIAANALGESIC, N.E.C.
75UNAPPROVED
6/11/2025Dabur India Ltd

Baddi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/11/2025Dabur India

Solan

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
6/11/2025AbbVie Deutschland GmbH & Co. KG

Ludwigshafen

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/11/2025HIMALAYA DRUG COMPANY

Bengaluru

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/11/2025PREVEGO HEALTHCARE & RESEARCH PV

St Fort Mumbai

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/11/2025AKESISS PHARMA PVT LTD

Kochi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/11/2025Mankind Pharma Ltd.

New Delhi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/11/2025CADILA PHARMACEUTICAL LTD

Ahmedabad

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/11/2025Franco-Indian Laboratories

Mumbai

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/11/2025PREVEGO HEALTHCARE & RESEARCH PV

St Fort Mumbai

INDIAPIOGLITAZONE MALEATE
75UNAPPROVED
6/11/2025USV Private Limited

Govandi

INDIAGLIPIZIDE (ANTI-DIABETIC)
75UNAPPROVED
6/11/2025Cipla Limited

Bengaluru

INDIACEFUROXIME SODIUM (CEPHALOSPORINS)
75UNAPPROVED
6/11/2025ZYDUS HEALTHCARE LTD

Bengaluru

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
6/11/2025PIRAMAL PHARMA LIMITED

Ennore

INDIASULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
6/11/2025PREVEGO HEALTHCARE & RESEARCH PV

St Fort Mumbai

INDIAEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
6/11/2025ELDER PROJECT LIMITED

Mumbai

INDIASITAGLIPTIN PHOSPHATE (ANTI-DIABETIC)
75UNAPPROVED
6/11/2025INTAS PHARMACEUTICALS

Karnataka

INDIAVITAMIN D2 (CALCIFEROL)
75UNAPPROVED
6/11/2025Cipla Limited

Bengaluru

INDIAATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
6/11/2025Grimann, S.A. de C.V.

Lerma

MEXICOAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
6/11/2025LIFERPAL MDS A DE CV

El Salto

MEXICOACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
6/11/2025Laboratorios Biofarma Sa De Cv

Jalisco

MEXICOFOLIC ACID (VITAMIN)
75UNAPPROVED
6/11/2025SRIDEEP PHARMA

Virar

INDIANEOMYCIN PALMITATE (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
6/11/2025GMT PHARMA INTERNATIONAL

Pradesh

INDIAWATER, PURIFIED (EYEWASH)
75UNAPPROVED
6/11/2025CIPLA LIMITED

New Delhi

INDIABENZOCAINE (ANESTHETIC)
75UNAPPROVED
6/11/2025DOLVIS BIO PHARMA PVT LTD

Chandigah

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
6/11/2025PSYCHOTROPICS INDIA LTD

Haryana

INDIAXYLOMETAZOLINE HCL (ADRENERGIC)
75UNAPPROVED
6/11/2025LIFEVISION HEALTHCARE PHARMA

Chandigarh

INDIAPHENYLEPHRINE HCL (ADRENERGIC)
75UNAPPROVED
6/11/2025LIFEVISION HEALTHCARE PHARMA

Chandigarh

INDIAEUCALYPTUS OIL (PHARMACEUTIC NECESSITY - FLAVOR)
75UNAPPROVED
1...461462463...10077

About This Page

This page displays 50 FDA import refusal records from 8 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 2380 (NO PMA/PDP), 341 (REGISTERED), 237 (NO PMA) and 2 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 462 of 10,077 • Showing records 23,051-23,100 of 503,850 total