Han Dok Alps Optical Co., Ltd
⚠️ Moderate Risk
FEI: 1000547432 • Kongju-S1 • SOUTH KOREA
FEI Number
1000547432
Location
Kongju-S1
Country
SOUTH KOREAAddress
540-1, Songsun-R1, Changgi-Myon, , Kongju-S1, , 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).
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/16/2008 | 57YC99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | New York District Office (NYK-DO) | |
| 10/13/2004 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Cincinnati District Office (CIN-DO) | |
| 4/18/2003 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Han Dok Alps Optical Co., Ltd's FDA import refusal history?
Han Dok Alps Optical Co., Ltd (FEI: 1000547432) has 3 FDA import refusal record(s) in our database, spanning from 4/18/2003 to 12/16/2008.
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. Han Dok Alps Optical Co., Ltd's FEI number is 1000547432.
What types of violations has Han Dok Alps Optical Co., Ltd received?
Han Dok Alps Optical Co., Ltd 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 Han Dok Alps Optical Co., Ltd come from?
All FDA import refusal data for Han Dok Alps Optical Co., 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.