Theg Korea, Inc.
⚠️ Moderate Risk
FEI: 3007071265 • Seoul • SOUTH KOREA
FEI Number
3007071265
Location
Seoul
Country
SOUTH KOREAAddress
726-74 Hannam-Dong, Suit 1009,, , Seoul, , 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
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 5/11/2011 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/21/2009 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Los Angeles District Office (LOS-DO) | |
| 8/21/2009 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Theg Korea, Inc.'s FDA import refusal history?
Theg Korea, Inc. (FEI: 3007071265) has 3 FDA import refusal record(s) in our database, spanning from 8/21/2009 to 5/11/2011.
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. Theg Korea, Inc.'s FEI number is 3007071265.
What types of violations has Theg Korea, Inc. received?
Theg Korea, Inc. has been cited for 3 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 Theg Korea, Inc. come from?
All FDA import refusal data for Theg Korea, Inc. 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.