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Aromatica Company

⚠️ Moderate Risk

FEI: 3011003249 • Seongnam, Gyeonggi • SOUTH KOREA

FEI

FEI Number

3011003249

📍

Location

Seongnam, Gyeonggi

🇰🇷
🏢

Address

177 Sagimakgol-Lo; Jungwon, , Seongnam, Gyeonggi, South Korea

Moderate Risk

FDA Import Risk Assessment

39.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
11/18/2015
Latest Refusal
11/18/2015
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
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

22803×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

753×

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
11/18/2015
53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
2280DIRSEXMPT
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/18/2015
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
2280DIRSEXMPT
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/18/2015
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
2280DIRSEXMPT
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Aromatica Company's FDA import refusal history?

Aromatica Company (FEI: 3011003249) has 3 FDA import refusal record(s) in our database, spanning from 11/18/2015 to 11/18/2015.

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. Aromatica Company's FEI number is 3011003249.

What types of violations has Aromatica Company received?

Aromatica Company 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 Aromatica Company come from?

All FDA import refusal data for Aromatica Company 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.