Import Refusal Records
503,850 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 12/9/2025 | AMI LIFESCIENCES PVT LTD Karakhadi | INDIA | SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) | |
| 12/9/2025 | AMI LIFESCIENCES PVT LTD Karakhadi | INDIA | BENZONATATE (ANTI-TUSSIVE/COLD) | |
| 12/9/2025 | AMI LIFESCIENCES PVT LTD Karakhadi | INDIA | TROMETHAMINE (ALKALIZER) | |
| 12/9/2025 | AMI LIFESCIENCES PVT LTD Karakhadi | INDIA | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | |
| 12/9/2025 | AMI LIFESCIENCES PVT LTD Karakhadi | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | |
| 12/9/2025 | AMI LIFESCIENCES PVT LTD Karakhadi | INDIA | ANTI-DIABETIC N.E.C. | |
| 12/9/2025 | AMI LIFESCIENCES PVT LTD Karakhadi | INDIA | MUCOLYTIC N.E.C. | |
| 12/9/2025 | AMI LIFESCIENCES PVT LTD Karakhadi | INDIA | ANTI-EMETIC/NAUSEANT N.E.C. | |
| 12/9/2025 | AMI LIFESCIENCES PVT LTD Karakhadi | INDIA | FENOFIBRATE (ANTI-CHOLESTEREMIC) | |
| 12/9/2025 | AMI LIFESCIENCES PVT LTD Karakhadi | INDIA | ANTI-HYPERTENSIVE N.E.C. | |
| 12/9/2025 | AMI LIFESCIENCES PVT LTD Karakhadi | INDIA | BRONCHODILATOR N.E.C. | |
| 12/9/2025 | Novaliq Gmbh Heidelberg | GERMANY | EMOLLIENT, LUBRICANT, N.E.C. | |
| 12/9/2025 | DreamCon Co. Ltd. Yangsan | SOUTH KORE | LENS, CONTACT (DISPOSABLE) | |
| 12/9/2025 | NAOKI IWASE Minato | JAPAN | LENS, CONTACT (DISPOSABLE) | |
| 12/9/2025 | NAOKI IWASE Minato | JAPAN | LENS, CONTACT (DISPOSABLE) | |
| 12/9/2025 | NAOKI IWASE Minato | JAPAN | LENS, CONTACT (DISPOSABLE) | |
| 12/9/2025 | NAOKI IWASE Minato | JAPAN | LENS, CONTACT (DISPOSABLE) | |
| 12/9/2025 | NAOKI IWASE Minato | JAPAN | LENS, CONTACT (DISPOSABLE) | |
| 12/9/2025 | NAOKI IWASE Minato | JAPAN | LENS, CONTACT (DISPOSABLE) | |
| 12/9/2025 | NAOKI IWASE Minato | JAPAN | LENS, CONTACT (DISPOSABLE) | |
| 12/9/2025 | GLOBAL-E C/O SWATI COSMETICS Skurup | SWEDEN | LENSES, SOFT CONTACT, EXTENDED WEAR | |
| 12/9/2025 | GLOBAL-E C/O SWATI COSMETICS Skurup | SWEDEN | LENSES, SOFT CONTACT, EXTENDED WEAR | |
| 12/9/2025 | OREON Life science co., Ltd Seongnam | SOUTH KORE | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | |
| 12/9/2025 | MUNA Jungnang District | SOUTH KORE | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | |
| 12/9/2025 | JETEMA CO LTD Yongin | SOUTH KORE | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | |
| 12/9/2025 | CRESCITA SKIN SCIENCES INC. Laval | CANADA | OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED |
| 12/9/2025 | ESCAMILLAS EXPRESS San Salvador | EL SALVADO | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 12/9/2025 | ESCAMILLAS EXPRESS San Salvador | EL SALVADO | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 12/9/2025 | Jiangxi Hemei Pharmaceutical Co., Ltd Yichun | CHINA | TOLNAFTATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED |
| 12/9/2025 | Divya Pharmacy Hardwar | INDIA | GYMNEMA SYLVESTRE (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED |
| 12/9/2025 | Astrazeneca Pharmaceuticals Co. Ltd. Jiangsu | CHINA | INHIBITOR (GROWTH FACTOR) N.E.C. | 75UNAPPROVED |
| 12/9/2025 | VIP PHARMACEUTICALS PVT LTD Solan | INDIA | CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED |
| 12/9/2025 | LABORATORIES SANOFI San Salvador | EL SALVADO | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 12/9/2025 | LABORATORIES SAIMED SA DE CV San Salvador | EL SALVADO | FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED |
| 12/9/2025 | LABORATORIOS FARDEL San Salvador | EL SALVADO | VITAMIN B1 (THIAMINE) | 75UNAPPROVED |
| 12/9/2025 | LABORATORIES ARSAL San Salvador | EL SALVADO | MEDROXYPROGESTERONE ACETATE (PROGESTIN) | 75UNAPPROVED |
| 12/9/2025 | HECHO EN MEXICO POR MERCK SA Guatemala | GUATEMALA | VITAMIN B1 (THIAMINE) | 75UNAPPROVED |
| 12/9/2025 | CAPLIN POINT Bodega | GUATEMALA | AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 12/9/2025 | SYNOKEM PHARMACEUTICALS LTD UTTARAKHAND | INDIA | NORETHINDRONE (PROGESTIN) | 75UNAPPROVED |
| 12/9/2025 | Akums Drugs & Pharma Ranipur | INDIA | VITAMIN D2 (CALCIFEROL) | 75UNAPPROVED |
| 12/9/2025 | SAI PRIMUS LIFEBIOTECH PVT LTD Puducherry | INDIA | MECOBALAMIN (VITAMIN) | 75UNAPPROVED |
| 12/9/2025 | sun pharma laboratories ltd Ranipool | INDIA | DIVALPROEX SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED |
| 12/9/2025 | Microlabs Limited South Sikkim | INDIA | LEVETIRACETAM (ANTI-CONVULSANT) | 75UNAPPROVED |
| 12/9/2025 | STEDMAN PHARMACEUTICALS Thiruporur | INDIA | DESONIDE (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 12/9/2025 | Hesa Pharmaceuticals Solan | INDIA | MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED |
| 12/9/2025 | GSK LABORATORY Guatemala | GUATEMALA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 12/9/2025 | ELI LILLY CANADA INC Toronto | CANADA | TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 12/9/2025 | NOVO NORDISK Mississauga | CANADA | SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 12/9/2025 | MANOSMAGICAS Naucalpan De Ju | MEXICO | INDOMETHACIN (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 12/9/2025 | Amgen Manufacturing Limited LLC Juncos | UNITED STA | ROMOSOZUMAB-AQQG | 75UNAPPROVED |
About This Page
This page displays 50 FDA import refusal records from 11 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 75 (UNAPPROVED), 508 (NO 510(K)), 237 (NO PMA). Each record links to detailed firm profiles with complete violation history and risk assessments.
Viewing page 69 of 10,077 • Showing records 3,401-3,450 of 503,850 total