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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
8/28/2025PLANTA SABRITAS GUADALAJARA

Zapopan

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
8/27/2025Greiner Bio-One GmbH

Kremsmunster

AUSTRIADEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC
118NOT LISTED
3280FRNMFGREG
+1 more
8/27/2025Sbs Cryo Tech Sa

Moreno

ARGENTINAANIMAL MEDICAL DEVICES, NEC
118NOT LISTED
3280FRNMFGREG
+1 more
8/27/2025BOE COSMETICS

Carolina

UNITED STAMINOXIDIL (ANTI-HYPERTENSIVE)
118NOT LISTED
3280FRNMFGREG
+1 more
8/27/2025Glaxosmithkline Argentina S.A.

Unknown

ARGENTINASODIUM BICARBONATE (REPLENISHER)
118NOT LISTED
3280FRNMFGREG
+1 more
8/27/2025Glaxosmithkline Argentina S.A.

Unknown

ARGENTINASODIUM BICARBONATE (REPLENISHER)
118NOT LISTED
3280FRNMFGREG
+1 more
8/27/2025Laboratorios Coaspharma

Bogota

COLOMBIAPREDNISONE (GLUCOCORTICOID)
118NOT LISTED
3280FRNMFGREG
+1 more
8/27/2025LABORATORIO FINLAY

San Pedro Sula

HONDURASACETAMINOPHEN (ANALGESIC)
118NOT LISTED
3280FRNMFGREG
+1 more
8/27/2025ESTANDARES INTERNACIONALES S DE

La Paz

HONDURASVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
8/27/2025INDUTRIAL FARMACEUTICA CANTABRIAS.A.

Santander

SPAINZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN)
118NOT LISTED
3280FRNMFGREG
8/27/2025Laboratorios Contifarma, C Por A.

Santo Domingo De Guzman

DOMINICAN MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
8/27/2025Glenmark Pharmaceuticals Limited

Solan

INDIAANTIFUNGAL N.E.C.
118NOT LISTED
27DRUG GMPS
+2 more
8/27/2025I.E. ULAGAY ILAC SANAYII

Istanbul

TURKEYCYPROHEPTADINE HCL (ANTI-HISTAMINIC)
118NOT LISTED
8/27/2025NICOPODS EHF

Sudurnesjabar

ICELANDNICOTINE POUCH
75UNAPPROVED
8/27/2025HECHO EN MEXICO

Coyoacan

MEXICODESVENLAFAXINE SUCCINATE
75UNAPPROVED
8/27/2025HECHO EN MEXICO

Coyoacan

MEXICOMETRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
8/27/2025HECHO EN MEXICO

Coyoacan

MEXICOPANTOPRAZOLE SODIUM
75UNAPPROVED
8/27/2025HAB PHARMACEUTICALS & RESEARCH

Dehradun

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/27/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICOSERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
8/27/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICOPREGABALIN (ANTI-CONVULSANT)
75UNAPPROVED
8/27/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICOROSUVASTATIN CALCIUM
75UNAPPROVED
8/27/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICOLEVAMISOLE HYDROCHLORIDE (ANTIPARASITIC)
75UNAPPROVED
8/27/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICODILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
8/27/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICOMETFORMIN HCL (ANTI-DIABETIC)
75UNAPPROVED
8/27/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICOLEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
8/27/2025MERCK S A

Mixco

GUATEMALAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
8/27/2025MERCK S A

Mixco

GUATEMALADICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
8/27/2025SELECTPHARMA

Guatemala

GUATEMALAALBENDAZOLE (ANTHELMINTIC)
75UNAPPROVED
8/27/2025Bayer S.A.

Guatemala

GUATEMALAGLUTAMIC ACID HCL (ACIDIFIER)
75UNAPPROVED
8/27/2025Bayer S.A.

Guatemala

GUATEMALAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
8/27/2025Bayer S.A.

Guatemala

GUATEMALAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
8/27/2025GNOSIS PHARMACEUTICALS PVT LTD

Sirmour

INDIAISOTRETINOIN (KERATOLYTIC)
75UNAPPROVED
8/27/2025Glenmark Pharmaceuticals Limited

Solan

INDIAITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
8/27/2025ERIS LIFESCIENCES LIMITED

Ahmedabad

INDIATACROLIMUS (IMMUNOSUPPRESSIVE)
75UNAPPROVED
8/27/2025Hesa Pharmaceuticals

Himachal Pradesh

INDIACLOBETASOL PROPIONATE (GLUCOCORTICOID)
75UNAPPROVED
8/27/2025Mankind Pharma Ltd.

New Delhi

INDIAKETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
8/27/2025Dabur India Ltd

Baddi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/27/2025Eli Lilly & Company

Indianapolis

UNITED STATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
8/27/2025SHANGHAI XH BUSINESS CO.LTD

Songjiang

CHINAALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS
47NON STD
476NO REGISTR
8/27/2025Intas Pharmaceuticals Limited

Ahmedabad

INDIAACETAMINOPHEN (ANALGESIC)
27DRUG GMPS
8/27/2025EVERRICH FOODS INDIA PVT LTD

Bengaluru

INDIAOTHER BAKERY PRODUCTS, N.E.C.
11UNSAFE COL
274COLOR LBLG
8/27/2025EVERRICH FOODS INDIA PVT LTD

Bengaluru

INDIAOTHER BAKERY PRODUCTS, N.E.C.
11UNSAFE COL
274COLOR LBLG
8/27/2025EVERRICH FOODS INDIA PVT LTD

Bengaluru

INDIAOTHER BAKERY PRODUCTS, N.E.C.
11UNSAFE COL
274COLOR LBLG
8/27/2025EVERRICH FOODS INDIA PVT LTD

Bengaluru

INDIAOTHER BAKERY PRODUCTS, N.E.C.
11UNSAFE COL
274COLOR LBLG
8/27/2025La Constancia Ltda. de C.V

San Salvador

EL SALVADOCARBONATED SOFT DRINK, N.E.C.
11UNSAFE COL
8/27/2025JAY CHIKKI & SNACKS PVT LTD

Mumbai

INDIAFLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH NUTS OR NUT PRODUCTS (NOT COCONUT OR SUCKERS)(WITHOUT
9SALMONELLA
8/27/2025BAIJAY INTERNATIONAL PRIVATE LIM

Valsad

INDIAFLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH NUTS OR NUT PRODUCTS (NOT COCONUT OR SUCKERS)(WITHOUT
9SALMONELLA
8/27/2025JAY CHIKKI & SNACKS PVT LTD

Mumbai

INDIAFLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH NUTS OR NUT PRODUCTS (NOT COCONUT OR SUCKERS)(WITHOUT
9SALMONELLA
8/27/2025JAY CHIKKI & SNACKS PVT LTD

Mumbai

INDIAFLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH NUTS OR NUT PRODUCTS (NOT COCONUT OR SUCKERS)(WITHOUT
9SALMONELLA
8/27/2025QUALITY SPICES & FOOD EXPORTS PVT.LTD.

Ambernath (E)

INDIAOTHER BAKERY PRODUCTS, N.E.C.
9SALMONELLA

About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 11 (UNSAFE COL), 118 (NOT LISTED), 3280 (FRNMFGREG), 476 (NO REGISTR), 341 (REGISTERED) and 5 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 313 of 10,077 • Showing records 15,601-15,650 of 503,850 total