Spi Lasers Uk Limited
⚠️ Moderate Risk
FEI: 3005388032 • Southhampton • UNITED KINGDOM
FEI Number
3005388032
Location
Southhampton
Country
UNITED KINGDOMAddress
Unit 3 Wellington Park, , Southhampton, , 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
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.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/11/2013 | 95RHKLASER MARKER OR ENGRAVER | 47NON STD | Los Angeles District Office (LOS-DO) |
| 11/2/2012 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 5/29/2012 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 6/29/2007 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | New Orleans District Office (NOL-DO) |
| 12/4/2006 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 11/9/2006 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 126FAILS STD | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Spi Lasers Uk Limited's FDA import refusal history?
Spi Lasers Uk Limited (FEI: 3005388032) has 6 FDA import refusal record(s) in our database, spanning from 11/9/2006 to 10/11/2013.
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. Spi Lasers Uk Limited's FEI number is 3005388032.
What types of violations has Spi Lasers Uk Limited received?
Spi Lasers Uk Limited has been cited for 2 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 Spi Lasers Uk Limited come from?
All FDA import refusal data for Spi Lasers Uk 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.