Genic Co Ltd

⚠️ Moderate Risk

FEI: 3004214756 • Seoul • SOUTH KOREA

FEI

FEI Number

3004214756

📍

Location

Seoul

🇰🇷

Country

SOUTH KOREA

🏢

Address

12310 Nophycon Dong, , Seoul, , South Korea

Moderate Risk

FDA Import Risk Assessment

33.8

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

6/14/2006

Latest Refusal

6/14/2006

Earliest Refusal

Score Breakdown

Violation Severity

55.0×40%

Refusal Volume

25.9×30%

Recency

0.0×20%

Frequency

40.0×10%

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

Violation Summary

1184×

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).

2234×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

Date	Product	Violations	Division
6/14/2006	66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 223FALSE	Los Angeles District Office (LOS-DO)
6/14/2006	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 223FALSE	Los Angeles District Office (LOS-DO)
6/14/2006	66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 223FALSE	Los Angeles District Office (LOS-DO)
6/14/2006	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 223FALSE	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Genic Co Ltd's FDA import refusal history?

Genic Co Ltd (FEI: 3004214756) has 4 FDA import refusal record(s) in our database, spanning from 6/14/2006 to 6/14/2006.

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. Genic Co Ltd's FEI number is 3004214756.

What types of violations has Genic Co Ltd received?

Genic Co Ltd 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 Genic Co Ltd come from?

All FDA import refusal data for Genic 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.