ImportRefusal LogoImportRefusal

Beauty Skin.Co., Ltd.

⚠️ Moderate Risk

FEI: 3015187479 • Seo, Incheon • SOUTH KOREA

FEI

FEI Number

3015187479

📍

Location

Seo, Incheon

🇰🇷
🏢

Address

27 Yeomgokro14beon-gil, , Seo, Incheon, South Korea

Moderate Risk

FDA Import Risk Assessment

30.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
11/15/2022
Latest Refusal
11/15/2022
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
11.2×30%
Recency
22.9×20%
Frequency
10.0×10%
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

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

Refusal History

DateProductViolationsDivision
11/15/2022
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
237NO PMA
3260NO ENGLISH
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Beauty Skin.Co., Ltd.'s FDA import refusal history?

Beauty Skin.Co., Ltd. (FEI: 3015187479) has 1 FDA import refusal record(s) in our database, spanning from 11/15/2022 to 11/15/2022.

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. Beauty Skin.Co., Ltd.'s FEI number is 3015187479.

What types of violations has Beauty Skin.Co., Ltd. received?

Beauty Skin.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 Beauty Skin.Co., Ltd. come from?

All FDA import refusal data for Beauty Skin.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.