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ELIXIR CO., LTD.

⚠️ Moderate Risk

FEI: 3015893469 • Kakegawa, Shizuoka • JAPAN

FEI

FEI Number

3015893469

📍

Location

Kakegawa, Shizuoka

🇯🇵

Country

JAPAN
🏢

Address

436-0047 1120, Nagaya, Kakegawa, Shizuoka, Japan

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
5/1/2020
Latest Refusal
5/1/2020
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

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.

4733×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
5/1/2020
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
Division of Northeast Imports (DNEI)
5/1/2020
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
Division of Northeast Imports (DNEI)
5/1/2020
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
Division of Northeast Imports (DNEI)

Frequently Asked Questions

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

ELIXIR CO., LTD. (FEI: 3015893469) has 3 FDA import refusal record(s) in our database, spanning from 5/1/2020 to 5/1/2020.

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. ELIXIR CO., LTD.'s FEI number is 3015893469.

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

ELIXIR 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 ELIXIR CO., LTD. come from?

All FDA import refusal data for ELIXIR 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.