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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
5/23/2025Dabur India Limited

Silvassa

INDIADENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
5/23/2025Biologische Heilmittel Heel Gmbh

Baden-Baden

GERMANYHOMEOPATHIC N.E.C.
75UNAPPROVED
5/23/2025WATER NEXT SOLUTIONS

New Delhi

INDIAPOTASSIUM CITRATE (ALKALIZER)
75UNAPPROVED
5/23/2025Inga Pharmaceuticals

Mumbai

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
5/23/2025Alkem Laboratories Ltd

Mumbai

INDIAPANTOPRAZOLE SODIUM
75UNAPPROVED
5/23/2025Pure And Cure Healthcare Pvt Ltd

Haridwar

INDIACIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
5/23/2025Medley Pharmaceuticals Ltd.

Mumbai

INDIADOMPERIDONE
75UNAPPROVED
5/23/2025MARTIN AND HARRIS LABORATORIES L

Delhi

INDIANITROFURANTOIN (ANTI-BACTERIAL)
75UNAPPROVED
5/23/2025LPCA LABORATORIES

MUMBAI

INDIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
5/23/2025SUN PHARMACEUTICAL INDUSTRIES

Mumbai

INDIAFLUOCINONIDE (GLUCOCORTICOID)
75UNAPPROVED
5/23/2025SANOFI INDIA LTD

Ankleshwar

INDIAIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
5/23/2025Centaur Pharmaceuticals

Mumbai

INDIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
5/23/2025Medley Pharmaceuticals Ltd.

Mumbai

INDIAOFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC)
75UNAPPROVED
5/23/2025MK

Bogota

COLOMBIACLOBETASOL PROPIONATE (GLUCOCORTICOID)
75UNAPPROVED
5/23/2025Glaxosmithkline Colombia S.A

Bogota

COLOMBIACLOBETASOL PROPIONATE (GLUCOCORTICOID)
75UNAPPROVED
5/23/2025GENPAV

Valle Del Cauca Cali

COLOMBIACLOBETASOL PROPIONATE (GLUCOCORTICOID)
75UNAPPROVED
5/23/2025NOVO NORDISK COLOMBIA SAS

Bogota

COLOMBIAANTI-DIABETIC N.E.C.
75UNAPPROVED
5/23/2025PRODUCTOS FARMACEUTICOS COLLINS

Zapopan

MEXICOLORATADINE (ANTI-ASTHMATIC)
75UNAPPROVED
5/23/2025Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)

Tlajomulco De Zuniga

MEXICOSODIUM CHLORIDE (REPLENISHER)
75UNAPPROVED
5/23/2025AGLAE PATRICIO GAL

Morelia

MEXICOANTI-HISTAMINIC N.E.C.
75UNAPPROVED
5/23/2025AGLAE PATRICIO GAL

Morelia

MEXICOCEFTRIAXONE SODIUM (CEPHALOSPORINS)
75UNAPPROVED
5/23/2025APOLLO PHARMACY

Hyderabad

INDIAPROSTAGLANDIN N.E.C.
75UNAPPROVED
5/23/2025ANDPHARMA

Etazh

COLOMBIASOMATROPIN
75UNAPPROVED
5/23/2025Dabur India Limited

Silvassa

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/23/2025IBRAHIM SALAH ORABI

Damascus

SYRIAOLIVES, GREEN, (PIT FRUIT)
62NEEDS FCE
83NO PROCESS
5/23/2025Xinxiang Tuoxin Pharmaceutical Co. Ltd

Xinxiang

CHINAANTIBIOTIC N.E.C.
27DRUG GMPS
5/23/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
+1 more
5/23/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
5/23/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+1 more
5/23/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+1 more
5/23/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+1 more
5/23/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+1 more
5/23/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+1 more
5/23/2025AL RAWDHA FOODSTUFF INDUSTRY

Ajman

UNITED ARASESAME SEED (EDIBLE SEED PASTE)
9SALMONELLA
5/23/2025AL RAWDHA FOODSTUFF INDUSTRY

Ajman

UNITED ARASESAME SEED (EDIBLE SEED PASTE)
9SALMONELLA
5/23/2025Gjedra

Berat

ALBANIASAGE, WHOLE (SPICE)
9SALMONELLA
5/23/2025AL RAWDHA FOODSTUFF INDUSTRY

Ajman

UNITED ARANON-STANDARDIZED MIXED NUT PRODUCT
9SALMONELLA
5/23/2025AL RAWDHA FOODSTUFF INDUSTRY

Ajman

UNITED ARASESAME SEED (EDIBLE SEED PASTE)
9SALMONELLA
5/22/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
5/22/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
5/22/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
5/22/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
5/22/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
5/22/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
5/22/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
5/22/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
5/22/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
5/22/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
5/22/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
5/22/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904

About This Page

This page displays 50 FDA import refusal records from 9 countries. Records on this page involve violations including 75 (UNAPPROVED), 62 (NEEDS FCE), 83 (NO PROCESS), 27 (DRUG GMPS), 11 (UNSAFE COL) and 7 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 504 of 10,077 • Showing records 25,151-25,200 of 503,850 total