Import Refusal Records
503,850 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 5/28/2025 | Boston Scientific Corporation Marlborough | UNITED STA | WIRE, GUIDE, CATHETER | 2480RXPERSONAL |
| 5/28/2025 | Boston Scientific Corporation Marlborough | UNITED STA | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE | 2480RXPERSONAL |
| 5/28/2025 | Boston Scientific Corporation Marlborough | UNITED STA | SYRINGE, BALLOON INFLATION | 2480RXPERSONAL |
| 5/28/2025 | Fujian Genohope Biotech Ltd Putian | CHINA | TIRZEPATIDE (ANTI-DIABETIC) | 2280DIRSEXMPT |
| 5/28/2025 | Fujian Genohope Biotech Ltd Putian | CHINA | TIRZEPATIDE (ANTI-DIABETIC) | 2280DIRSEXMPT |
| 5/28/2025 | Stc India Pvt. Ltd. Mumbai | INDIA | MANGO (SUBTROPICAL AND TROPICAL FRUIT) | 2040SULFITELBL |
| 5/28/2025 | OPTOSOFT Hoddesdon | UNITED KIN | LENSES, SOFT CONTACT, EXTENDED WEAR | 508NO 510(K) |
| 5/28/2025 | Caregen Co., Ltd. Gunpo | SOUTH KORE | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 508NO 510(K) |
| 5/28/2025 | TTK HEALTHCARE LIMITED - PROTECTIVE DEVICES DIVISION Virudhunager | INDIA | CONDOM | 508NO 510(K) |
| 5/28/2025 | BEIJING HOTGEN BIOTECH CO LTD Beijing | CHINA | COVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) |
| 5/28/2025 | Bedfont Scientific, Ltd. Maidstone | UNITED KIN | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 508NO 510(K) |
| 5/28/2025 | ALTRUAN GMBH Massing | GERMANY | GENERAL PURPOSE REAGENT | 508NO 510(K) |
| 5/28/2025 | ALTRUAN GMBH Massing | GERMANY | COVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) |
| 5/28/2025 | ALTRUAN GMBH Massing | GERMANY | GENERAL PURPOSE REAGENT | 508NO 510(K) |
| 5/28/2025 | Guangzhou Navo Industry Co., Ltd. Guangzhou | CHINA | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 482NUTRIT LBL |
| 5/28/2025 | DOLCEZZE DI RIVIERA S.R.L. Varazze | ITALY | NUT SPREADS WITH FLAVORINGS (E.G. NUTELLA) | 482NUTRIT LBL |
| 5/28/2025 | SSL Manufacturing (Thailand) LTD. Bang Pakong | THAILAND | CONDOM | 477HOLES |
| 5/28/2025 | SSL Manufacturing (Thailand) LTD. Bang Pakong | THAILAND | CONDOM | 477HOLES |
| 5/28/2025 | SSL Manufacturing (Thailand) LTD. Bang Pakong | THAILAND | CONDOM | 477HOLES |
| 5/28/2025 | TAEYOUNG S E M CO LTD Shihung-Shi Shihung-S | SOUTH KORE | ALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS | 476NO REGISTR |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
| 5/28/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | 473LABELING |
About This Page
This page displays 50 FDA import refusal records from 9 countries. Records on this page involve violations including 2480 (RXPERSONAL), 2280 (DIRSEXMPT), 2040 (SULFITELBL), 508 (NO 510(K)), 482 (NUTRIT LBL) and 3 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.
Viewing page 489 of 10,077 • Showing records 24,401-24,450 of 503,850 total