Import Refusal Records
503,850 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 9/18/2025 | GOPOP HK LIMITED Dubai | UNITED ARA | LENS, CONTACT (DISPOSABLE) | |
| 9/18/2025 | FARMA-DERMA SRL Sala Bolognese | ITALY | MISCELLANEOUS PATENT MEDICINES, ETC. | |
| 9/18/2025 | FARMAMEDICA SA Huehuetenango | GUATEMALA | IBUPROFEN (ANTI-INFLAMMATORY) | |
| 9/18/2025 | FARMAMEDICA SA Huehuetenango | GUATEMALA | VITAMIN C (ASCORBIC ACID) | |
| 9/18/2025 | FARMAMEDICA SA Huehuetenango | GUATEMALA | DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | |
| 9/18/2025 | ENCUBE ETHICALS Mardol | INDIA | FATS AND LIPID SUBSTANCES, N.E.C. | |
| 9/18/2025 | ENCUBE ETHICALS Mardol | INDIA | CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | |
| 9/18/2025 | ENCUBE ETHICALS Mardol | INDIA | CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | |
| 9/18/2025 | ENCUBE ETHICALS Mardol | INDIA | AZELAIC ACID (ANTI-SEBORRHEIC) | |
| 9/18/2025 | ENCUBE ETHICALS Mardol | INDIA | FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | |
| 9/18/2025 | ENCUBE ETHICALS Mardol | INDIA | BENZOYL PEROXIDE (KERATOLYTIC) | |
| 9/18/2025 | CANIXA LIFE SCIENCES PVT LTD IND UTTARAKHAND | INDIA | NICOTINAMIDE (NIACINAMIDE) (VITAMIN) | |
| 9/18/2025 | CANIXA LIFE SCIENCES PVT LTD IND UTTARAKHAND | INDIA | PEPTIDE N.E.C. | |
| 9/18/2025 | CANIXA LIFE SCIENCES PVT LTD IND UTTARAKHAND | INDIA | NICOTINAMIDE (NIACINAMIDE) (VITAMIN) | |
| 9/18/2025 | CANIXA LIFE SCIENCES PVT LTD IND UTTARAKHAND | INDIA | BENZOYL PEROXIDE (KERATOLYTIC) | |
| 9/18/2025 | PHARMACEUTICAL RESEARCH ASSOCIAT Lomas De Chapultepec | MEXICO | LEVOTHYROXINE SODIUM (THYROID HORMONE) | |
| 9/18/2025 | ARISTO PHARMACEUTICALS Mumbai | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | |
| 9/18/2025 | HEALING PHARMA INDIA PVT LTD Mumbai | INDIA | IVERMECTIN AND COMBINATIONS (ANTIPARASITIC) | |
| 9/18/2025 | Salus Pharmaceuticals Teh. Baddi | INDIA | IVERMECTIN AND COMBINATIONS (ANTIPARASITIC) | |
| 9/18/2025 | QUINFICA LABORATORY Guatemala | GUATEMALA | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | |
| 9/18/2025 | LANKETIN Guatemala City | GUATEMALA | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | |
| 9/18/2025 | QUINFICA LABORATORY Guatemala | GUATEMALA | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | |
| 9/18/2025 | DAVIS SA Guatemala City | GUATEMALA | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | |
| 9/18/2025 | OXYMORON AG Lorrach | GERMANY | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/18/2025 | MERCK SL Barcelona | SPAIN | METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED |
| 9/18/2025 | BGP PRODUCTS SRL Rome | ITALY | METHIONINE (ACIDIFIER) | 75UNAPPROVED |
| 9/18/2025 | Cutyx Research LLP Ahmedabad | INDIA | RAMELTEON (HYPNOTIC) | 75UNAPPROVED |
| 9/18/2025 | Laboratorios Leon Farma SAU Navatejera | SPAIN | PROGESTERONE (PROGESTIN) | 75UNAPPROVED |
| 9/18/2025 | Sanofi-Aventis De Mexico Ocoyoacac | MEXICO | DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED |
| 9/18/2025 | LOEFLER SA DE CV Hidalgo | MEXICO | AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED |
| 9/18/2025 | Bayer de Mexico, S.A. de C.V. Lerma | MEXICO | LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED |
| 9/18/2025 | PRODUCTOS FARAMACEUTICOS Aguascalientes | MEXICO | AMANTADINE HCL (ANTI-VIRAL) | 75UNAPPROVED |
| 9/18/2025 | OMEGA NUTRITION Hidalgo Del Parral | MEXICO | GLUCOSAMINE SULFATE (HERBAL AND BOTANICALS, NOT TEAS II) | 75UNAPPROVED |
| 9/18/2025 | INDOCO REMEDIES LTD AURANGABAD | INDIA | SIMETHICONE (ANTI-FLATULENT) | 75UNAPPROVED |
| 9/18/2025 | Janssen Inc. North York | CANADA | USTEKINUMAB | 75UNAPPROVED |
| 9/18/2025 | IPCA LABORATORIES Bharichola | INDIA | CHLORZOXAZONE (RELAXANT) | 75UNAPPROVED |
| 9/18/2025 | MANIKAND PHARMA LTD South Sikkim | INDIA | ACYCLOVIR; HYDROCORTISONE (ANTI-VIRAL) | 75UNAPPROVED |
| 9/18/2025 | AMRITALAYA HERBS & NUTRACEUTICAL Lucknow | INDIA | ANALGESIC, N.E.C. | 75UNAPPROVED |
| 9/18/2025 | AMRITALAYA HERBS & NUTRACEUTICAL Lucknow | INDIA | ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED |
| 9/18/2025 | SHREE BARDYANATH AYURVED Howrah | INDIA | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED |
| 9/18/2025 | AMRITALAYA HERBS & NUTRACEUTICAL Lucknow | INDIA | PILOCARPINE NITRATE (CHOLINERGIC) | 75UNAPPROVED |
| 9/18/2025 | MG MEDICS Haryana | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/18/2025 | ELEXX PHARMA Haryana | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/18/2025 | ABBOTT INDIA LIMITED VERNA SALCETTE GOA | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/18/2025 | MEDICANT NUTRIENT Ganaur | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/18/2025 | UNIQUE BIOTECH LIMITED Hyderabad | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/18/2025 | Intas Pharmaceuticals Limited Ahmedabad | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/18/2025 | SUN PHARMA MEDISALES PVT LTD Baddi | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/18/2025 | Wizcure Pharmaa Private Limited Bhiwadi | INDIA | FLUORESCEIN SODIUM (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED |
| 9/18/2025 | ECO PRODUCTS JOINT STOCK COMPANY Hanoi | VIETNAM | WATER CHESTNUT (ROOT & TUBER VEGETABLE) |
About This Page
This page displays 50 FDA import refusal records from 9 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 75 (UNAPPROVED), 62 (NEEDS FCE), 83 (NO PROCESS). Each record links to detailed firm profiles with complete violation history and risk assessments.
Viewing page 265 of 10,077 • Showing records 13,201-13,250 of 503,850 total