SMYLIE LTD
⚠️ Moderate Risk
FEI: 3008217787 • Birkenhead, Merseyside • UNITED KINGDOM
FEI Number
3008217787
Location
Birkenhead, Merseyside
Country
UNITED KINGDOMAddress
Unit 14a, 15 Valley Road Business Park, Birkenhead, Merseyside, 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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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 |
|---|---|---|---|
| 7/31/2013 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/31/2013 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/31/2013 | 53BH01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/31/2013 | 29BCT01SOFT DRINK, BERRY FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Division of Southeast Imports (DSEI) |
| 7/31/2013 | 37KCT23CURRY PASTE | 11UNSAFE COL | Division of Southeast Imports (DSEI) |
| 7/31/2013 | 29BCT03SOFT DRINK, CORE FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Division of Southeast Imports (DSEI) |
| 7/31/2013 | 29BCT03SOFT DRINK, CORE FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Division of Southeast Imports (DSEI) |
| 7/31/2013 | 20CCT12RASPBERRY, BLACK, JAM, JELLY, PRESERVES, MARMALADE, BUTTER AND CANDIED | 11UNSAFE COL | Division of Southeast Imports (DSEI) |
| 4/6/2011 | 34FGT02CHOCOLATE CANDY PIECES, WITHOUT NUTS AND FRUIT | 11UNSAFE COL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is SMYLIE LTD's FDA import refusal history?
SMYLIE LTD (FEI: 3008217787) has 9 FDA import refusal record(s) in our database, spanning from 4/6/2011 to 7/31/2013.
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. SMYLIE LTD's FEI number is 3008217787.
What types of violations has SMYLIE LTD received?
SMYLIE LTD 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 SMYLIE LTD come from?
All FDA import refusal data for SMYLIE 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.