Import Refusal Records
503,850 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 6/16/2025 | LABORATORIOS PISA Coyoacan | MEXICO | PREGABALIN (ANTI-CONVULSANT) | 75UNAPPROVED |
| 6/16/2025 | H & CARE Haryana | INDIA | CHLORZOXAZONE (RELAXANT) | 75UNAPPROVED |
| 6/16/2025 | CELANTIS HEALTHCARE Kundli | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 6/16/2025 | MICRO LABSLTD Bengaluru | INDIA | PIROXICAM (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 6/16/2025 | LXIR MEDILABS PRIVATE Panchkula | INDIA | VITAMIN, N.E.C. | 75UNAPPROVED |
| 6/16/2025 | CELANTIS HEALTHCARE Kundli | INDIA | VITAMIN A | 75UNAPPROVED |
| 6/16/2025 | EMZOR PHARM. IND. LTD Lagos | NIGERIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 6/16/2025 | GSK Ilupeju Lagos | NIGERIA | AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 6/16/2025 | Novo Nordisk A/S Bagsvard | DENMARK | SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 6/16/2025 | ROYALDAY COMPANY LIMITED Tsim Sha Tsui | HONG KONG | PEPTIDE N.E.C. | 75UNAPPROVED |
| 6/16/2025 | WELLCHEM PHARMACEUTICALS PTB LTD Singapore | SINGAPORE | ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED |
| 6/16/2025 | GREAT EAST ASIA TRADING COMPANYLTD Kowloon | HONG KONG | METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED |
| 6/16/2025 | Intas Pharmaceuticals Limited Ahmedabad | INDIA | SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED |
| 6/16/2025 | Novo Nordisk A/S Kalundborg | DENMARK | SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 6/16/2025 | Eli Lilly Italia SPA Sesto Fiorentino | ITALY | ANTI-PSORIATIC N.E.C. | 75UNAPPROVED |
| 6/16/2025 | INSTITUTO HOMEM Sao Paulo | BRAZIL | MACA (HERBAL & BOTANICALS, NOT TEAS II) | 75UNAPPROVED |
| 6/16/2025 | INSTITUTO HOMEM Sao Paulo | BRAZIL | L-ARGININE (PROTEIN) | 75UNAPPROVED |
| 6/16/2025 | INSTITUTO HOMEM Sao Paulo | BRAZIL | TRIBULUS (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED |
| 6/16/2025 | INSTITUTO HOMEM Sao Paulo | BRAZIL | TRIBULUS (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED |
| 6/14/2025 | Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S. Cekmekoy | TURKEY | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS |
| 6/14/2025 | Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S. Cekmekoy | TURKEY | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS |
| 6/14/2025 | Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S. Cekmekoy | TURKEY | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS |
| 6/13/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | |
| 6/13/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | |
| 6/13/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | |
| 6/13/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | |
| 6/13/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | |
| 6/13/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | |
| 6/13/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | |
| 6/13/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | |
| 6/13/2025 | Swedish Match Ab Stockholm | DENMARK | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | DENMARK | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | DENMARK | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | XQS INTERNATIONAL AB Borlange | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE POUCH | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE POUCH | 3854TPLKUSSLLB |
| 6/13/2025 | Swedish Match Ab Stockholm | DENMARK | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
About This Page
This page displays 50 FDA import refusal records from 10 countries. Records on this page involve violations including 75 (UNAPPROVED), 27 (DRUG GMPS), 3904 (3904), 3905 (3905), 3854 (TPLKUSSLLB). Each record links to detailed firm profiles with complete violation history and risk assessments.
Viewing page 457 of 10,077 • Showing records 22,801-22,850 of 503,850 total