SANG HEE KIM
⚠️ High Risk
FEI: 3041249274 • Sejong, Sejong • SOUTH KOREA
FEI Number
3041249274
Location
Sejong, Sejong
Country
SOUTH KOREAAddress
Sasa Ro, Doum 5-Ro, Sejong, Sejong, South Korea
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 1/2/2026 | 86MRCPRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE | Division of Southeast Imports (DSEI) | |
| 1/2/2026 | 86MWLLENS, CONTACT (RIGID GAS PERMEABLE) - EXTENDED WEAR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SANG HEE KIM's FDA import refusal history?
SANG HEE KIM (FEI: 3041249274) has 2 FDA import refusal record(s) in our database, spanning from 1/2/2026 to 1/2/2026.
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. SANG HEE KIM's FEI number is 3041249274.
What types of violations has SANG HEE KIM received?
SANG HEE KIM 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 SANG HEE KIM come from?
All FDA import refusal data for SANG HEE KIM 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.