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LLC WAY OF BEAUTY

⚠️ Moderate Risk

FEI: 3022024144 • Kremenchug • UKRAINE

FEI

FEI Number

3022024144

📍

Location

Kremenchug

🇺🇦

Country

UKRAINE
🏢

Address

Igor Serduka Str 37/18, , Kremenchug, , Ukraine

Moderate Risk

FDA Import Risk Assessment

29.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
4/25/2022
Latest Refusal
4/25/2022
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
11.2×30%
Recency
11.7×20%
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

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
4/25/2022
79LCJEXPANDER, SKIN, INFLATABLE
118NOT LISTED
3280FRNMFGREG
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LLC WAY OF BEAUTY's FDA import refusal history?

LLC WAY OF BEAUTY (FEI: 3022024144) has 1 FDA import refusal record(s) in our database, spanning from 4/25/2022 to 4/25/2022.

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. LLC WAY OF BEAUTY's FEI number is 3022024144.

What types of violations has LLC WAY OF BEAUTY received?

LLC WAY OF BEAUTY 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 LLC WAY OF BEAUTY come from?

All FDA import refusal data for LLC WAY OF BEAUTY 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.