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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
3/4/2025HOME HEALTH STORE

Edmonton

CANADASODIUM CHLORIDE (REPLENISHER)
75UNAPPROVED
3/4/2025Prosperity Drugs Pvt. Ltd

Distt. Solan

INDIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
3/4/2025Dr. Reddy's Laboratories Ltd.

Medchal-Malkajgiri District

INDIACETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC)
75UNAPPROVED
3/4/2025FDC LTD

Maharashtra

INDIACEFIXIME (CEPHALOSPORINS)
75UNAPPROVED
3/4/2025Encube Ethicals Pvt. Ltd.

Ponda

INDIACALAMINE (PROTECTANT)
75UNAPPROVED
3/4/2025Laboratorios Quimica Son's, S.A. de C.V.

Heroica Puebla De Zaragoza

MEXICOPRECIPITATED CALCIUM CARBONATE (ANTACID)
75UNAPPROVED
3/4/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICOVITAMIN B1 (THIAMINE)
75UNAPPROVED
3/4/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICOHYDROXOCOBALAMIN (VITAMIN)
75UNAPPROVED
3/4/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICOHYDROXOCOBALAMIN (VITAMIN)
75UNAPPROVED
3/4/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICOVITAMIN C (ASCORBIC ACID)
75UNAPPROVED
3/4/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICOVITAMIN B1 (THIAMINE)
75UNAPPROVED
3/4/2025Laboratorios Quimica Son's, S.A. de C.V.

Heroica Puebla De Zaragoza

MEXICOVITAMIN B1 (THIAMINE)
75UNAPPROVED
3/4/2025Laboratorios Quimica Son's, S.A. de C.V.

Heroica Puebla De Zaragoza

MEXICOSULFATHIAZOLE
75UNAPPROVED
3/4/2025Laboratorios Quimica Son's, S.A. de C.V.

Heroica Puebla De Zaragoza

MEXICOACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
3/4/2025Laboratorios Quimica Son's, S.A. de C.V.

Heroica Puebla De Zaragoza

MEXICOBETAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
3/4/2025Trividia Health, Inc.

Fort Lauderdale

UNITED STAANTI-DIABETIC N.E.C.
75UNAPPROVED
3/4/2025BEHOPE.CA

Scarborough

CANADAINTRODUCER, SYRINGE NEEDLE
75UNAPPROVED
3/4/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASWEET GOODS WITHOUT CUSTARD OR CREAM FILLING, N.E.C.
62NEEDS FCE
83NO PROCESS
3/4/2025Intas Pharmaceuticals Limited

Ahmedabad

INDIANAPHAZOLINE HCL (ADRENERGIC)
27DRUG GMPS
75UNAPPROVED
3/4/2025GUANGZHOU HFFS FOOD CO.LTD

Guangzhou

CHINASYRUPS AND MOLASSES, N.E.C.
11UNSAFE COL
258FLAVR LBLG
+3 more
3/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+5 more
3/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+5 more
3/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+5 more
3/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+5 more
3/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+5 more
3/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+5 more
3/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+5 more
3/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOPOTATO CHIPS,FRIED
11UNSAFE COL
218LIST INGRE
+5 more
3/4/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
3/4/2025ANOTHER SNUS FACTORY STOCKHOLM AB

Stockholm

SWEDENSNUS
3842TP NO PMTA
3843TP NO SE
+1 more
3/4/2025ANOTHER SNUS FACTORY STOCKHOLM AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3/4/2025ANOTHER SNUS FACTORY STOCKHOLM AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3/4/2025ANOTHER SNUS FACTORY STOCKHOLM AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3/4/2025FUZHOU CHENFENGXING IMPORT AND EXPORT TRADING CO., LTD.

Fuzhou

CHINAZWEIBACK, TOAST
3421MELAMINE
3/4/2025FUZHOU CHENFENGXING IMPORT AND EXPORT TRADING CO., LTD.

Fuzhou

CHINAOTHER BAKERY PRODUCTS, N.E.C.
3421MELAMINE
3/4/2025FUZHOU CHENFENGXING IMPORT AND EXPORT TRADING CO., LTD.

Fuzhou

CHINAOTHER BAKERY PRODUCTS, N.E.C.
3421MELAMINE
3/4/2025Future Diagnostics Solutions B.V.

Wijchen

NETHERLANDIMMUNOASSAY METHOD, TROPONIN SUBUNIT
2780DEVICEGMPS
3/4/2025PA-Siam Intertrade Co. Ltd.

Yannawa

THAILANDPLUM (PIT FRUIT)
2640CYCLAMATE
3844SACCHARLBL
3/4/2025PA-Siam Intertrade Co. Ltd.

Yannawa

THAILANDMANGO (SUBTROPICAL AND TROPICAL FRUIT)
2640CYCLAMATE
3844SACCHARLBL
3/4/2025SOCIETE DE CONSERVERIE EN AFRIQUE (SCA S.A.)

Dakar

SENEGALTUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
2360HISTAMINE
3/4/2025SOCIETE DE CONSERVERIE EN AFRIQUE (SCA S.A.)

Dakar

SENEGALTUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
2360HISTAMINE
3/4/2025ANDROMEDICAL SL

Madrid

SPAINDEVICE, EXTERNAL PENILE RIGIDITY
508NO 510(K)
3/4/2025ANDROMEDICAL SL

Madrid

SPAINDEVICE, EXTERNAL PENILE RIGIDITY
508NO 510(K)
3/4/2025FUZHOU TONGKOU WHITE CRANE RICE-FLOUR NOODLES CO.,LTD

Fuzhou

CHINARICE FLAKES,PUFFS,KRISPIES,LOOPS READY TO EAT
473LABELING
3/4/2025Irecosmetics Co., Ltd.

Namdong

SOUTH KOREMOISTURIZING (SKIN CARE PREPARATIONS)
473LABELING
3/4/2025YIWU ZIQIU IMPORT EXPORT CO LTD

Jiangdong Sub-District

CHINAMOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
3/4/2025YIWU ZIQIU IMPORT EXPORT CO LTD

Jiangdong Sub-District

CHINAMOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
3/4/2025YIWU ZIQIU IMPORT EXPORT CO LTD

Jiangdong Sub-District

CHINAMOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
3/4/2025YIWU ZIQIU IMPORT EXPORT CO LTD

Jiangdong Sub-District

CHINAMOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
3/4/2025BROW CODE PTY LTD

Molendinar

AUSTRALIAEYELASH AND EYEBROW TREATMENTS-GEL, OIL, PRIMER, CONDITIONERS, SERUM, FORTIFIERS (EYE MAKEUP PREPARA
471CSTIC LBLG

About This Page

This page displays 50 FDA import refusal records from 13 countries. Records on this page involve violations including 75 (UNAPPROVED), 62 (NEEDS FCE), 83 (NO PROCESS), 27 (DRUG GMPS), 11 (UNSAFE COL) and 22 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 648 of 10,077 • Showing records 32,351-32,400 of 503,850 total