THG OMEGA AND ICON
⚠️ Moderate Risk
FEI: 3023618630 • Warrington, WRT • UNITED KINGDOM
FEI Number
3023618630
Location
Warrington, WRT
Country
UNITED KINGDOMAddress
Omega South, Dri; Skyline Drive, Warrington, WRT, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/17/2024 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/17/2024 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/17/2024 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/17/2024 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/17/2024 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/3/2023 | 76JESFLOSS, DENTAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is THG OMEGA AND ICON's FDA import refusal history?
THG OMEGA AND ICON (FEI: 3023618630) has 6 FDA import refusal record(s) in our database, spanning from 5/3/2023 to 9/17/2024.
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. THG OMEGA AND ICON's FEI number is 3023618630.
What types of violations has THG OMEGA AND ICON received?
THG OMEGA AND ICON 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 THG OMEGA AND ICON come from?
All FDA import refusal data for THG OMEGA AND ICON 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.