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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
6/4/2025PROCTOR AND GAMBLE MANUFACTURING

Ahmedabad

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/4/2025Abbot Healthcare Pvt Ltd

Baddi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/4/2025Zentiva Private Limited

Ankleshwar

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/4/2025JB CHEMICALS AND PARMACEUTICALS

Ahmedabad

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/4/2025UNITED BIOCEUTICALS PRIVATE LIMI

Haridwar

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/4/2025LASSANA TRAORE

Bamako

MALIHOMEOPATHIC N.E.C.
75UNAPPROVED
6/4/2025SHRI SAI MARKET

Haryana

INDIAMONTELUKAST SODIUM (ANTI-ASTHMATIC)
75UNAPPROVED
6/4/2025ALLENGE INDIA

Bhoj Tipra

INDIALEVOFLOXACIN (ANTI-BACTERIAL, PART III)
75UNAPPROVED
6/4/2025BIOMAX BIOTECHNICS PVT LTD

Haryana

INDIANUTRIENT/TONIC N.E.C.
75UNAPPROVED
6/4/2025Sun Pharmaceutical Industries Ltd.

Halol

INDIAIVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
27DRUG GMPS
75UNAPPROVED
6/4/2025Similasan AG

Jonen

SWITZERLANEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
27DRUG GMPS
6/4/2025TRT C.A.

Puerto Miranda

VENEZUELACOOKIE,BISCUIT,WAFER DOUGH, N.E.C.
11UNSAFE COL
482NUTRIT LBL
6/4/2025Inversiones Asaf S de RL de CV

El Negrito

HONDURASFRIED SNACK FOODS, N.E.C.
11UNSAFE COL
218LIST INGRE
+2 more
6/4/2025Swizzels Matlow Limited

High Peak

UNITED KINHARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
6/4/2025Shree Bhagwati Flour & Foods PVT. LTD

Changodar

INDIAFRIED SNACK FOODS, N.E.C.
9SALMONELLA
6/4/2025Song Tran Import and Export Co., Ltd

Duc Hoa District

VIETNAMSCAD
9SALMONELLA
6/3/2025UNIMED UNIHEALTH PHARMACEUTICALS

Dhaka

BANGLADESHMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/3/2025UNIMED UNIHEALTH PHARMACEUTICALS

Dhaka

BANGLADESHMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/3/2025Square Pharmaceuticals PLC

Gazipur

BANGLADESHMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/3/2025ACI FOODS LTD

Dhaka

BANGLADESHMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/3/2025CORPORACION BARMI SA

San Salvador

EL SALVADOCEPHALEXIN (CEPHALOSPORINS)
75UNAPPROVED
6/3/2025Ferrer Internacional S.A.

Barcelona

SPAINHYDROCORTISONE ACETATE (GLUCOCORTICOID)
75UNAPPROVED
6/3/2025DISFARMACO SRL

Santo Domingo

DOMINICAN LORATADINE (ANTI-ASTHMATIC)
75UNAPPROVED
6/3/2025NOVOCAP SA

Carlos Spegazzini

ARGENTINAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
6/3/2025Genomma Laboratories

Mexico

MEXICOPHENYLEPHRINE HCL (ADRENERGIC)
75UNAPPROVED
6/3/2025LABORATORIOS SUIPHAR

Santo Domingo

DOMINICAN ACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
6/3/2025SPRING PHARMA

Zurich

SWITZERLANACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
6/3/2025LABORATORIO BRITANIA

Manoguyabo Santao Dom

DOMINICAN DICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
6/3/2025MEGAPHARMA LABS

Canelones

URUGUAYMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/3/2025MEGAPHARMA LABS

Canelones

URUGUAYGUAIFENESIN (EXPECTORANT)
75UNAPPROVED
6/3/2025MEGAPHARMA LABS

Canelones

URUGUAYAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
6/3/2025Amsa Laboratories

Mexico City

MEXICOOLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II
75UNAPPROVED
6/3/2025FARMACON SA DE CV

Culiacan

MEXICOFLUOXETINE (ANTI-DEPRESSANT)
75UNAPPROVED
6/3/2025Armstrong Laboratorios De Mexico S.A. De C.V.

Mexico

MEXICOTRANQUILIZER (ANTI-PSYCHOTIC) - PART II N.E.C.
75UNAPPROVED
6/3/2025SCOPE OPHTHALMICS

Crawley

UNITED KINWATER, PURIFIED (EYEWASH)
75UNAPPROVED
6/3/2025Jewim Pharmaceutical (Shandong) Co., Ltd.

Taian

CHINAOXYMETAZOLINE HCL (ADRENERGIC)
75UNAPPROVED
6/3/2025Novo Nordisk

Bangalore

INDIASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
6/3/2025EMS SA

Sao Paulo

BRAZILDEXAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
6/3/2025Uniao Qulmica Farmaceutica Nacio

Embu

BRAZILLEVONORGESTREL (ESTROGEN)
75UNAPPROVED
6/3/2025AVN Ayurveda Formulations Private Limited

Madurai

INDIAASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
6/3/2025RAJASTHAN AUSHDHALAYA PVT LTD

Maharashtra

INDIAASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
6/3/2025CIPLA LIMITED

Mumbai

INDIAANTACID, N.E.C.
75UNAPPROVED
6/3/2025The Market S.A. de C.V.

San Salvador

EL SALVADOMILK, FLAVORED, LOW FAT
62NEEDS FCE
83NO PROCESS
6/3/2025CHANGCHUN SUNDAY OPTICS CO LTD

Changchun

CHINALASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
47NON STD
476NO REGISTR
6/3/2025DORAT AL SAYAB FOR TRADING CO

Basra

IRAQSOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
321LACKS N/C
+1 more
6/3/2025DORAT AL SAYAB FOR TRADING CO

Basra

IRAQSOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
321LACKS N/C
+1 more
6/3/2025DORAT AL SAYAB FOR TRADING CO

Basra

IRAQSOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
321LACKS N/C
+1 more
6/3/2025DORAT AL SAYAB FOR TRADING CO

Basra

IRAQSOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
321LACKS N/C
+1 more
6/3/2025DORAT AL SAYAB FOR TRADING CO

Basra

IRAQSOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
321LACKS N/C
+1 more
6/3/2025DORAT AL SAYAB FOR TRADING CO

Basra

IRAQSOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
321LACKS N/C
+1 more
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About This Page

This page displays 50 FDA import refusal records from 17 countries. Records on this page involve violations including 75 (UNAPPROVED), 27 (DRUG GMPS), 11 (UNSAFE COL), 482 (NUTRIT LBL), 218 (LIST INGRE) and 8 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 477 of 10,077 • Showing records 23,801-23,850 of 503,850 total