Scorpio Worldwide Ltd-Intl House
✅ Low Risk
FEI: 3010339034 • West, Essex • UNITED KINGDOM
FEI Number
3010339034
Location
West, Essex
Country
UNITED KINGDOMAddress
Unit D, Old Brighton Rd, Lowfield Heath, West, Essex, United Kingdom
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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 |
|---|---|---|---|
| 10/21/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/21/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/21/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Scorpio Worldwide Ltd-Intl House's FDA import refusal history?
Scorpio Worldwide Ltd-Intl House (FEI: 3010339034) has 3 FDA import refusal record(s) in our database, spanning from 10/21/2013 to 10/21/2013.
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. Scorpio Worldwide Ltd-Intl House's FEI number is 3010339034.
What types of violations has Scorpio Worldwide Ltd-Intl House received?
Scorpio Worldwide Ltd-Intl House 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 Scorpio Worldwide Ltd-Intl House come from?
All FDA import refusal data for Scorpio Worldwide Ltd-Intl House 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.