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YESTOTOM CO., LTD.

⚠️ Moderate Risk

FEI: 3014681557 • Seoul • SOUTH KOREA

FEI

FEI Number

3014681557

📍

Location

Seoul

🇰🇷
🏢

Address

15-10 Shinhang Ro, , Seoul, , South Korea

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
5/13/2019
Latest Refusal
4/10/2019
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

4712×

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.

4752×

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
5/13/2019
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
75UNAPPROVED
Division of West Coast Imports (DWCI)
4/10/2019
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
475COSMETLBLG
Division of West Coast Imports (DWCI)
4/10/2019
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
475COSMETLBLG
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is YESTOTOM CO., LTD.'s FDA import refusal history?

YESTOTOM CO., LTD. (FEI: 3014681557) has 3 FDA import refusal record(s) in our database, spanning from 4/10/2019 to 5/13/2019.

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. YESTOTOM CO., LTD.'s FEI number is 3014681557.

What types of violations has YESTOTOM CO., LTD. received?

YESTOTOM CO., LTD. has been cited for 3 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 YESTOTOM CO., LTD. come from?

All FDA import refusal data for YESTOTOM 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.