Sun Bon
⚠️ Moderate Risk
FEI: 3007700308 • Daejeon • SOUTH KOREA
FEI Number
3007700308
Location
Daejeon
Country
SOUTH KOREAAddress
606 JoongDo Vanture Town #306, Seo-Gu Tanbang-Dong, Daejeon, , South Korea
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/28/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Seattle District Office (SEA-DO) | |
| 11/28/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Seattle District Office (SEA-DO) | |
| 11/28/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Seattle District Office (SEA-DO) | |
| 8/5/2011 | 86MVNLENS, CONTACT (DISPOSABLE) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Sun Bon's FDA import refusal history?
Sun Bon (FEI: 3007700308) has 4 FDA import refusal record(s) in our database, spanning from 8/5/2011 to 11/28/2012.
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. Sun Bon's FEI number is 3007700308.
What types of violations has Sun Bon received?
Sun Bon 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 Sun Bon come from?
All FDA import refusal data for Sun Bon 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.