Funky Eyes
⚠️ Moderate Risk
FEI: 3008144263 • Alford, Lincolnshire • UNITED KINGDOM
FEI Number
3008144263
Location
Alford, Lincolnshire
Country
UNITED KINGDOMAddress
3 Norman Terrace, Beechings Way, Alford, Lincolnshire, 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
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 |
|---|---|---|---|
| 12/6/2011 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | New Orleans District Office (NOL-DO) | |
| 12/6/2011 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 12/6/2011 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/5/2011 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/2/2011 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/2/2011 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/2/2011 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/2/2011 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/2/2011 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 10/26/2011 | 86MVNLENS, CONTACT (DISPOSABLE) | 237NO PMA | Philadelphia District Office (PHI-DO) |
| 10/7/2010 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Funky Eyes's FDA import refusal history?
Funky Eyes (FEI: 3008144263) has 11 FDA import refusal record(s) in our database, spanning from 10/7/2010 to 12/6/2011.
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. Funky Eyes's FEI number is 3008144263.
What types of violations has Funky Eyes received?
Funky Eyes has been cited for 4 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 Funky Eyes come from?
All FDA import refusal data for Funky Eyes 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.