Kunwha Optical Co.
⚠️ Moderate Risk
FEI: 1000241163 • Daegu • SOUTH KOREA
FEI Number
1000241163
Location
Daegu
Country
SOUTH KOREAAddress
23-2 Sinchon 3-Dong, , Dong-Gu, Daegu, , 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2013 | 86HOYSHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) | New Orleans District Office (NOL-DO) | |
| 10/16/2013 | 86HQZFRAME, SPECTACLE | New Orleans District Office (NOL-DO) | |
| 5/17/2013 | 86HQZFRAME, SPECTACLE | Detroit District Office (DET-DO) | |
| 3/22/2013 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Kunwha Optical Co.'s FDA import refusal history?
Kunwha Optical Co. (FEI: 1000241163) has 4 FDA import refusal record(s) in our database, spanning from 3/22/2013 to 10/16/2013.
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. Kunwha Optical Co.'s FEI number is 1000241163.
What types of violations has Kunwha Optical Co. received?
Kunwha Optical Co. 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 Kunwha Optical Co. come from?
All FDA import refusal data for Kunwha Optical Co. 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.