Dixons Surgical Instruments Ltd.
⚠️ Moderate Risk
FEI: 3004028778 • Wickford, Essex • UNITED KINGDOM
FEI Number
3004028778
Location
Wickford, Essex
Country
UNITED KINGDOMAddress
Oban Court, Wickford Business Park; 1 Hurricane Way, Wickford, Essex, 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
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/14/2014 | 74DQRCANNULA, CATHETER | Detroit District Office (DET-DO) | |
| 11/22/2013 | 78KNWINSTRUMENT, BIOPSY | Detroit District Office (DET-DO) | |
| 11/22/2013 | 79DWONEEDLE, BIOPSY, CARDIOVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/12/2011 | 78KNWINSTRUMENT, BIOPSY | New Orleans District Office (NOL-DO) | |
| 11/3/2009 | 79DWONEEDLE, BIOPSY, CARDIOVASCULAR | Detroit District Office (DET-DO) | |
| 3/12/2008 | 79DWONEEDLE, BIOPSY, CARDIOVASCULAR | 118NOT LISTED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Dixons Surgical Instruments Ltd.'s FDA import refusal history?
Dixons Surgical Instruments Ltd. (FEI: 3004028778) has 6 FDA import refusal record(s) in our database, spanning from 3/12/2008 to 1/14/2014.
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. Dixons Surgical Instruments Ltd.'s FEI number is 3004028778.
What types of violations has Dixons Surgical Instruments Ltd. received?
Dixons Surgical Instruments Ltd. has been cited for 6 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 Dixons Surgical Instruments Ltd. come from?
All FDA import refusal data for Dixons Surgical Instruments Ltd. 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.