ELUCEDA LTD
⚠️ High Risk
FEI: 3030969512 • Burnley, Lancashire • UNITED KINGDOM
FEI Number
3030969512
Location
Burnley, Lancashire
Country
UNITED KINGDOMAddress
Unit 3, Caroline Court; Billington Road, Burnley, Lancashire, United Kingdom
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/11/2024 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 126FAILS STD | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ELUCEDA LTD's FDA import refusal history?
ELUCEDA LTD (FEI: 3030969512) has 1 FDA import refusal record(s) in our database, spanning from 7/11/2024 to 7/11/2024.
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. ELUCEDA LTD's FEI number is 3030969512.
What types of violations has ELUCEDA LTD received?
ELUCEDA LTD has been cited for 1 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 ELUCEDA LTD come from?
All FDA import refusal data for ELUCEDA 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.