DX PRODUCTS LIMITED
⚠️ Moderate Risk
FEI: 3010386378 • Horbury Wakefield, West Yorkshire • UNITED KINGDOM
FEI Number
3010386378
Location
Horbury Wakefield, West Yorkshire
Country
UNITED KINGDOMAddress
Unit 1, Horbury Junction Industrial Estate; Calder Vale Road, Horbury Wakefield, West Yorkshire, United Kingdom
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/29/2025 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/25/2024 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 3/20/2024 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 12/15/2023 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/14/2023 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/14/2023 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/14/2023 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/7/2023 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 12/7/2023 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 7/31/2023 | 80QJYINFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DX PRODUCTS LIMITED's FDA import refusal history?
DX PRODUCTS LIMITED (FEI: 3010386378) has 10 FDA import refusal record(s) in our database, spanning from 7/31/2023 to 5/29/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. DX PRODUCTS LIMITED's FEI number is 3010386378.
What types of violations has DX PRODUCTS LIMITED received?
DX PRODUCTS LIMITED has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about DX PRODUCTS LIMITED come from?
All FDA import refusal data for DX PRODUCTS LIMITED is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.