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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
11/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/7/2025Naturelle LLC

Ras Al Khaimah

UNITED ARAHAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
197COSM COLOR
11/7/2025PEGAVISION CORPORATION

Taoyuan City

TAIWANLENS, CONTACT (DISPOSABLE)
118NOT LISTED
3280FRNMFGREG
+1 more
11/7/2025Piramal Healthcare (Canada) Ltd.

Aurora

CANADARESEARCH USE ONLY/CLINICAL CHEMISTRY DEVICES
118NOT LISTED
3280FRNMFGREG
+1 more
11/7/2025ZOETIS

Foz Do Iguacu

BRAZILIMMUNOMODULATOR N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
11/7/2025CORDX INC

Lakeside

UNITED STACOVID-19 MULTI-ANALYTE ANTIGEN DEVICE
118NOT LISTED
3280FRNMFGREG
11/7/2025PT ESSILOR INDONESIA

Jakarta

INDONESIASUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
3280FRNMFGREG
11/7/2025WAMA BV.

Terwispel

NETHERLANDACCESSORIES, CLEANING, FOR ENDOSCOPE
118NOT LISTED
3280FRNMFGREG
11/7/2025DUKSAN PURE CHEMICALS

Gyeonggi Do

SOUTH KOREMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
11/7/2025VENOGEN BIOCHEMICALS

Hong Kong

HONG KONGACIDIFIER N.E.C.
118NOT LISTED
11/7/2025VENOGEN BIOCHEMICALS

Hong Kong

HONG KONGINVESTIGATIONAL USE ONLY - CLINICAL CHEMISTRY
118NOT LISTED
11/7/2025Boe Dominicana SRL

Santo Domingo

DOMINICAN OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
75UNAPPROVED
11/7/2025VENOGEN BIOCHEMICALS

Hong Kong

HONG KONGDIAGOSTIC AID (DRUGS) N.E.C.
75UNAPPROVED
11/7/2025DUKSAN PURE CHEMICALS

Gyeonggi Do

SOUTH KOREANTI-DEPRESSANT N.E.C.
75UNAPPROVED
11/7/2025Eli Lilly And Company Pvt Ltd

Gurgaon

INDIATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
11/7/2025GOLD FOOD RESOURCES SDN BHD

Ipoh

MALAYSIATADALAFIL
75UNAPPROVED
11/7/2025Pfizer Manufacturing Belgium NV

Puurs-Sint-Amands

BELGIUMETANERCEPT
75UNAPPROVED
11/7/2025PIO PHARM CO., LTD.

Hwaseong

SOUTH KOREVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
11/7/2025Cosmax Bio, Inc.

Jecheon

SOUTH KOREVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
11/7/2025Dongkook Pharmaceutical Co., Ltd.

Seoul

SOUTH KOREREGULATOR N.E.C.
75UNAPPROVED
11/7/2025Eli Lilly Italia SPA

Sesto Fiorentino

ITALYTIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
11/7/2025Dr. Willmar Schwabe India Pvt. Ltd.

Sikandrabad

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/7/2025MICRO LABS LTD

Bangalore

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
11/7/2025BACTERIAL INFECTIONS

Gujarat

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
11/7/2025STEADFAST MEDISHIELD PVT LTD

Uttar Pradesh

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
11/7/2025FrieslandCampina WAMCO Nigeria PLC

Ikeja

NIGERIAMILK AND CREAM, N.E.C.
62NEEDS FCE
83NO PROCESS
11/7/2025Canton Laboratories Private Ltd.

Vadodara

INDIAPHARMACEUTIC NECESSITIES, N.E.C.
27DRUG GMPS
11/7/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025Sabritas S. de R.L. de C.V. Planta Saltillo

Saltillo

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025Sabritas S. de R.L. de C.V. Planta Saltillo

Saltillo

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025Sabritas S. de R.L. de C.V. Planta Saltillo

Saltillo

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025Sabritas S. de R.L. de C.V. Planta Saltillo

Saltillo

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025Sabritas S. de R.L. de C.V. Planta Saltillo

Saltillo

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025Sabritas S. de R.L. de C.V. Planta Saltillo

Saltillo

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025Sabritas S. de R.L. de C.V. Planta Saltillo

Saltillo

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025Sabritas S. de R.L. de C.V. Planta Saltillo

Saltillo

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025Sabritas S. de R.L. de C.V. Planta Saltillo

Saltillo

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025SABRITAS S.A. DE C.V.

Saltillo

MEXICOWHEAT GRAIN SNACK (WHOLE, CRACKED, SPLIT), FRIED/OIL COOKED
11UNSAFE COL
274COLOR LBLG
11/7/2025SABRITAS S.A. DE C.V.

Saltillo

MEXICOWHEAT GRAIN SNACK (WHOLE, CRACKED, SPLIT), FRIED/OIL COOKED
11UNSAFE COL
274COLOR LBLG
11/7/2025SABRITAS S.A. DE C.V.

Saltillo

MEXICOWHEAT GRAIN SNACK (WHOLE, CRACKED, SPLIT), FRIED/OIL COOKED
11UNSAFE COL
274COLOR LBLG
11/7/2025SABRITAS S.A. DE C.V.

Saltillo

MEXICOWHEAT GRAIN SNACK (WHOLE, CRACKED, SPLIT), FRIED/OIL COOKED
11UNSAFE COL
274COLOR LBLG
11/7/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/7/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG

About This Page

This page displays 50 FDA import refusal records from 17 countries. Records on this page involve violations including 3854 (TPLKUSSLLB), 197 (COSM COLOR), 118 (NOT LISTED), 3280 (FRNMFGREG), 508 (NO 510(K)) and 8 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 105 of 10,038 • Showing records 5,201-5,250 of 501,854 total