Import Refusal Records
503,850 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 12/2/2025 | EMBECTA CANADA CO Mississauga | CANADA | INJECTOR, PEN | 508NO 510(K) |
| 12/2/2025 | PT. Bahari Makmur Sejati Serang | INDONESIA | SHRIMP & PRAWNS, BREADED | |
| 12/2/2025 | PT. Bahari Makmur Sejati Serang | INDONESIA | SHRIMP & PRAWNS, BREADED | |
| 12/2/2025 | PT. Bahari Makmur Sejati Serang | INDONESIA | SHRIMP & PRAWNS, BREADED | |
| 12/2/2025 | PT. Bahari Makmur Sejati Serang | INDONESIA | SHRIMP & PRAWNS, BREADED | |
| 12/2/2025 | SAAMS INSTRUMENTS Sialkot | PAKISTAN | CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP |
| 12/2/2025 | ZHENGZHOU SYNEAR FOOD CO., LTD. Zhengzhou | CHINA | SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. | |
| 12/2/2025 | ZHENGZHOU SYNEAR FOOD CO., LTD. Zhengzhou | CHINA | SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. | |
| 12/2/2025 | QUALITY SPICES & FOOD EXPORTS PVT.LTD. Ambernath (E) | INDIA | COCONUT, SHELLED | |
| 12/2/2025 | QUALITY SPICES & FOOD EXPORTS PVT.LTD. Ambernath (E) | INDIA | COCONUT, SHELLED | |
| 12/2/2025 | QUALITY SPICES & FOOD EXPORTS PVT.LTD. Ambernath (E) | INDIA | COCONUT, SHELLED | |
| 12/2/2025 | QUALITY SPICES & FOOD EXPORTS PVT.LTD. Ambernath (E) | INDIA | COCONUT, SHELLED | |
| 12/2/2025 | GHANTA FOODS PVT LTD Nandiwanaparthy | INDIA | TAMARIND, DRIED OR PASTE | 249FILTHY |
| 12/2/2025 | GHANTA FOODS PVT LTD Nandiwanaparthy | INDIA | TAMARIND, DRIED OR PASTE | 249FILTHY |
| 12/2/2025 | MYANMAR ZARLA DISTRIBUTION COMPANY LIMITED Yangon | MYANMAR | TAMARIND, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT | 249FILTHY |
| 12/2/2025 | NATUR AGUI S DE RL DE CV Abasolo | MEXICO | STRAWBERRIES (BERRY) | 241PESTICIDE |
| 12/2/2025 | ABBOTT DIAGNOSTICS KOREA INC Yongin | SOUTH KORE | PLASMODIUM SPP. DETECTION REAGENTS | |
| 12/2/2025 | E11EMENT INC. Scarborough | CANADA | MISCELLANEOUS PATENT MEDICINES, ETC. | |
| 12/2/2025 | VENOGEN BIOCHEMICALS Hong Kong | HONG KONG | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | |
| 12/2/2025 | VENOGEN BIOCHEMICALS Hong Kong | HONG KONG | ANTI-DEPRESSANT N.E.C. | |
| 12/2/2025 | Kolmar Korea Co., Ltd. Sejong | SOUTH KORE | MISCELLANEOUS PATENT MEDICINES, ETC. | |
| 12/2/2025 | Shiseido Co Tokyo | JAPAN | TITANIUM DIOXIDE (PROTECTANT) | |
| 12/2/2025 | NIPRO THAILAND CORP LTD Ayuthaya | THAILAND | PROTECTOR, TRANSDUCER, DIALYSIS | 118NOT LISTED |
| 12/2/2025 | NIPRO THAILAND CORP LTD Ayuthaya | THAILAND | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | 118NOT LISTED |
| 12/2/2025 | NIPRO THAILAND CORP LTD Ayuthaya | THAILAND | CATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED |
| 12/2/2025 | NIPRO THAILAND CORP LTD Ayuthaya | THAILAND | HEMODIALYSIS CATHETER | 118NOT LISTED |
| 12/2/2025 | Dabur India Solan | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 12/2/2025 | LICENCIA LABS Tegucigalpa | HONDURAS | DOXYCYCLINE (TETRACYCLINES) | 75UNAPPROVED |
| 12/2/2025 | LABORATORIO ANDIFAR Tegucigalpa | HONDURAS | CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | 75UNAPPROVED |
| 12/2/2025 | CIPLA LTD Tamilnadu | INDIA | ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED |
| 12/2/2025 | MILLENNIUM HERBAL CARE LTD Navi Mumbai | INDIA | AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED |
| 12/2/2025 | MILLENNIUM HERBAL CARE LTD Navi Mumbai | INDIA | KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED |
| 12/2/2025 | Glenmark Pharmaceuticals Limited Solan | INDIA | CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED |
| 12/2/2025 | EMS PHARMA Hortolandia | BRAZIL | OLMESARTAN MEDOXOMIL | 75UNAPPROVED |
| 12/2/2025 | Pfizer Manhattan | UNITED STA | VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED |
| 12/2/2025 | Pfizer Manhattan | UNITED STA | AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED |
| 12/2/2025 | Lonza Chemie Ag Basel | SWITZERLAN | MONOCLONAL ANTIBODY, NEC | 75UNAPPROVED |
| 12/2/2025 | TRANSWIDE PHARMACEUTICALS LTD Nairobi | KENYA | BISACODYL (CATHARTIC) | 75UNAPPROVED |
| 12/2/2025 | TRANSWIDE PHARMACEUTICALS LTD Nairobi | KENYA | METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED |
| 12/2/2025 | TRANSWIDE PHARMACEUTICALS LTD Nairobi | KENYA | LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED |
| 12/2/2025 | TRANSWIDE PHARMACEUTICALS LTD Nairobi | KENYA | NEOMYCIN SULFATE (AMINOGLYCOSIDES) | 75UNAPPROVED |
| 12/2/2025 | SYNERMED PHARMACEUTICALS LTD Nairobi | KENYA | DOCUSATE SODIUM (STOOL SOFTENER) | 75UNAPPROVED |
| 12/2/2025 | TRANSWIDE PHARMACEUTICALS LTD Nairobi | KENYA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 12/2/2025 | QUINFICA LABORATORY Guatemala | GUATEMALA | VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED |
| 12/2/2025 | LABORATORIOS SANTA FE S.A. Guatemala | GUATEMALA | VITAMIN, N.E.C. | 75UNAPPROVED |
| 12/2/2025 | LAFAGE Guatemala | GUATEMALA | VITAMIN E (TOCOPHEROL) | 75UNAPPROVED |
| 12/2/2025 | CONAMEP LABORATORY Villa Nueva | GUATEMALA | VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED |
| 12/2/2025 | DONOVAN Guatemala | GUATEMALA | VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED |
| 12/2/2025 | LANKETIN Guatemala | GUATEMALA | VITAMIN, N.E.C. | 75UNAPPROVED |
| 12/2/2025 | LABORATORIOS Y DROGUERIA San Lucas Sacat | GUATEMALA | VITAMIN E (TOCOPHEROL) | 75UNAPPROVED |
About This Page
This page displays 50 FDA import refusal records from 17 countries. Records on this page involve violations including 508 (NO 510(K)), 308 (MFR INSAN), 3821 (MFR INJ), 290 (DE IMP GMP), 251 (POISONOUS) and 10 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.
Viewing page 85 of 10,077 • Showing records 4,201-4,250 of 503,850 total