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Jg Cosmetics Co Ltd

⚠️ Moderate Risk

FEI: 3007635959 • Chungbuk • SOUTH KOREA

FEI

FEI Number

3007635959

📍

Location

Chungbuk

🇰🇷
🏢

Address

5173 Deokamri Naesueub, , Chungbuk, , South Korea

Moderate Risk

FDA Import Risk Assessment

29.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
6
Unique Violations
8/13/2013
Latest Refusal
7/27/2009
Earliest Refusal

Score Breakdown

Violation Severity
56.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
7.4×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

1182×

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).

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

29401×

COSM MISB

The cosmetic's labeling appears to be false or misleading within the meaning of Section 201(n).

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

4751×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
8/13/2013
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)
8/13/2013
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)
7/27/2009
53LF99OTHER SKIN CARE PREPARATIONS, N.E.C.
2940COSM MISB
335LACKS N/C
475COSMETLBLG
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Jg Cosmetics Co Ltd's FDA import refusal history?

Jg Cosmetics Co Ltd (FEI: 3007635959) has 3 FDA import refusal record(s) in our database, spanning from 7/27/2009 to 8/13/2013.

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. Jg Cosmetics Co Ltd's FEI number is 3007635959.

What types of violations has Jg Cosmetics Co Ltd received?

Jg Cosmetics Co Ltd has been cited for 6 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 Jg Cosmetics Co Ltd come from?

All FDA import refusal data for Jg Cosmetics 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.