Import Refusal Records
503,850 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 4/14/2025 | ABBOTT HEALTHCARE GUJARAT | INDIA | CEFIXIME (CEPHALOSPORINS) | 75UNAPPROVED |
| 4/14/2025 | Cipla, Ltd. Dist. Pune | INDIA | ANALGESIC, N.E.C. | 75UNAPPROVED |
| 4/14/2025 | GLAXO Worli | INDIA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 4/14/2025 | Cipla, Ltd. Dist. Pune | INDIA | ADRENERGIC N.E.C. | 75UNAPPROVED |
| 4/14/2025 | ESSENDANT Tai Po | HONG KONG | PEPTIDE N.E.C. | 75UNAPPROVED |
| 4/14/2025 | SMART LABORATORIES PVT Ahmedabad | INDIA | A-FUNGAL N.E.C. | 75UNAPPROVED |
| 4/14/2025 | GLAXOSMITHKLINE PHARMACEUTICALS Bangalore | INDIA | LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED |
| 4/14/2025 | ELISTA PHARMACEUTICAL Kelambakkam Chennal | INDIA | ANTACID, N.E.C. | 75UNAPPROVED |
| 4/14/2025 | MASCUR PHARMAA INDIA PVT LTD PUDUCHERRY | INDIA | OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED |
| 4/14/2025 | Pfizer Limited Pune | INDIA | ALKALIZER, N.E.C. | 75UNAPPROVED |
| 4/14/2025 | MEDGUARD REMEDIES Tamilnadu | INDIA | SUPPRESSANT N.E.C. | 75UNAPPROVED |
| 4/14/2025 | F. Hoffmann-La Roche AG Basel Town | SWITZERLAN | TOCILIZUMAB | 75UNAPPROVED |
| 4/14/2025 | F. Hoffmann-La Roche AG Basel Town | SWITZERLAN | TOCILIZUMAB | 75UNAPPROVED |
| 4/14/2025 | ANTIBIOTICOS DE MEXICO, S.A. DE Coyoacan | MEXICO | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 4/14/2025 | PRODUCTOS MAVER S.A. DE C.V. Tlaquepaque | MEXICO | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 4/14/2025 | LABORATORIOS BEST SA Iztapalapa | MEXICO | ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED |
| 4/14/2025 | LABORATORIOS BEST SA Iztapalapa | MEXICO | IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 4/14/2025 | Laboratorios Quimica Son's, S.A. de C.V San Andres Cholula | MEXICO | NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 4/14/2025 | Laboratorios Quimica Son's, S.A. de C.V San Andres Cholula | MEXICO | ANALGESIC, N.E.C. | 75UNAPPROVED |
| 4/14/2025 | Laboratorios Quimica Son's, S.A. de C.V San Andres Cholula | MEXICO | MECLIZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED |
| 4/14/2025 | NATCO PHARMA LTD Hyderabad | INDIA | METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED |
| 4/14/2025 | Ziska Pharmaceuticals Ltd. Banglasdesh | INDIA | SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 4/14/2025 | ADELMAR PHARMA GMBH New Delhi | INDIA | HOMEOPATHIC N.E.C. | 75UNAPPROVED |
| 4/14/2025 | ZYDUS HEALTH CAR Duga | INDIA | CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED |
| 4/14/2025 | Comercializadora Pepsico Mexico, Ciudad De Mexico | MEXICO | POTATO CHIPS,FRIED | |
| 4/14/2025 | Comercializadora Pepsico Mexico, Ciudad De Mexico | MEXICO | POTATO CHIPS,FRIED | |
| 4/14/2025 | Comercializadora Pepsico Mexico, Ciudad De Mexico | MEXICO | CORN CHIPS, FRIED | |
| 4/14/2025 | Zenith Drinks Pvt.Ltd. New Delhi | INDIA | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | |
| 4/11/2025 | THONG THUAN - CAM RANH SEAFOOD JOINT STOCK COMPANY - EXPORT SEAFOOD PROCESSING FACTORY - CAM RANH Cam Lam | VIETNAM | SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS | 3885POIS CHLOR |
| 4/11/2025 | Fiedler & Lundgren Ab Malmo | SWEDEN | SNUS | 3854TPLKUSSLLB |
| 4/11/2025 | Gn Tobacco Sweden Ab Bispgarden | SWEDEN | SNUS | 3854TPLKUSSLLB |
| 4/11/2025 | Fiedler & Lundgren Ab Malmo | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 4/11/2025 | Lydia Co Ltd. Goyang | SOUTH KORE | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 3845DRG REF EI |
| 4/11/2025 | Lydia Co Ltd. Goyang | SOUTH KORE | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 3845DRG REF EI |
| 4/11/2025 | Lydia Co Ltd. Goyang | SOUTH KORE | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 3845DRG REF EI |
| 4/11/2025 | Lydia Co Ltd. Goyang | SOUTH KORE | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 3845DRG REF EI |
| 4/11/2025 | Lydia Co Ltd. Goyang | SOUTH KORE | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 3845DRG REF EI |
| 4/11/2025 | THE SNUS FACTPRY Odeshog | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | |
| 4/11/2025 | 77 POUCHES Cracow | POLAND | NICOTINE POUCH | 3842TP NO PMTA |
| 4/11/2025 | 77 POUCHES Cracow | POLAND | NICOTINE POUCH | 3842TP NO PMTA |
| 4/11/2025 | 77 POUCHES Cracow | POLAND | NICOTINE POUCH | 3842TP NO PMTA |
| 4/11/2025 | 77 POUCHES Cracow | POLAND | NICOTINE POUCH | 3842TP NO PMTA |
| 4/11/2025 | 77 POUCHES Cracow | POLAND | NICOTINE POUCH | 3842TP NO PMTA |
| 4/11/2025 | 77 POUCHES Cracow | POLAND | NICOTINE POUCH | 3842TP NO PMTA |
| 4/11/2025 | MAKE WEBO AB Uppsala | SWEDEN | NICOTINE POUCH | 3842TP NO PMTA |
| 4/11/2025 | THE SNUS FACTPRY Odeshog | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3842TP NO PMTA |
| 4/11/2025 | MAKE WEBO AB Uppsala | SWEDEN | NICOTINE POUCH | 3842TP NO PMTA |
| 4/11/2025 | PREMIUM POUCH FINLAND OY Helsinki | FINLAND | NICOTINE DELIVERY PRODUCT, NEC | 3842TP NO PMTA |
| 4/11/2025 | GILO INTERNATIONAL London | UNITED KIN | NICOTINE DELIVERY PRODUCT, NEC | 3842TP NO PMTA |
| 4/11/2025 | MICROZERO AB Goteborg | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3842TP NO PMTA |
About This Page
This page displays 50 FDA import refusal records from 10 countries. Records on this page involve violations including 75 (UNAPPROVED), 11 (UNSAFE COL), 274 (COLOR LBLG), 3885 (POIS CHLOR), 3854 (TPLKUSSLLB) and 2 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.
Viewing page 580 of 10,077 • Showing records 28,951-29,000 of 503,850 total