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Gowoonsesang Cosmetics Co Ltd

⚠️ Moderate Risk

FEI: 3008623815 • Seoul, Seoul • SOUTH KOREA

FEI

FEI Number

3008623815

📍

Location

Seoul, Seoul

🇰🇷
🏢

Address

Shindang 4 Dong 3f, , Seoul, Seoul, South Korea

Moderate Risk

FDA Import Risk Assessment

45.3
LowModerateHighCritical

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

Statistics

8
Total Refusals
4
Unique Violations
12/27/2012
Latest Refusal
6/27/2011
Earliest Refusal

Score Breakdown

Violation Severity
73.3×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
53.2×10%
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

757×

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).

4713×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

1181×

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).

3301×

UNSAFE COL

The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).

Refusal History

DateProductViolationsDivision
12/27/2012
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
12/27/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/27/2011
64XBL06SALICYLIC ACID (KERATOLYTIC)
471CSTIC LBLG
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/27/2011
64XBL06SALICYLIC ACID (KERATOLYTIC)
471CSTIC LBLG
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/27/2011
64XBL06SALICYLIC ACID (KERATOLYTIC)
471CSTIC LBLG
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/27/2011
64XBL06SALICYLIC ACID (KERATOLYTIC)
118NOT LISTED
330UNSAFE COL
Los Angeles District Office (LOS-DO)
6/27/2011
64XBL06SALICYLIC ACID (KERATOLYTIC)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/27/2011
64XBL06SALICYLIC ACID (KERATOLYTIC)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

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

Gowoonsesang Cosmetics Co Ltd (FEI: 3008623815) has 8 FDA import refusal record(s) in our database, spanning from 6/27/2011 to 12/27/2012.

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. Gowoonsesang Cosmetics Co Ltd's FEI number is 3008623815.

What types of violations has Gowoonsesang Cosmetics Co Ltd received?

Gowoonsesang Cosmetics 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 Gowoonsesang Cosmetics Co Ltd come from?

All FDA import refusal data for Gowoonsesang 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.