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ELFA LABORATORY

⚠️ Moderate Risk

FEI: 3012846779 • Kiev, Kyiv • UKRAINE

FEI

FEI Number

3012846779

📍

Location

Kiev, Kyiv

🇺🇦

Country

UKRAINE
🏢

Address

Sosninykh sim�i vul. 9, , Kiev, Kyiv, Ukraine

Moderate Risk

FDA Import Risk Assessment

27.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
10/11/2013
Latest Refusal
10/11/2013
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

4714×

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.

Refusal History

DateProductViolationsDivision
10/11/2013
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Division of Northeast Imports (DNEI)
10/11/2013
53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS)
471CSTIC LBLG
Division of Northeast Imports (DNEI)
10/11/2013
53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS)
471CSTIC LBLG
Division of Northeast Imports (DNEI)
10/11/2013
53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS)
471CSTIC LBLG
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is ELFA LABORATORY's FDA import refusal history?

ELFA LABORATORY (FEI: 3012846779) has 4 FDA import refusal record(s) in our database, spanning from 10/11/2013 to 10/11/2013.

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. ELFA LABORATORY's FEI number is 3012846779.

What types of violations has ELFA LABORATORY received?

ELFA LABORATORY has been cited for 1 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 ELFA LABORATORY come from?

All FDA import refusal data for ELFA LABORATORY 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.