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Iaso, Inc.

⚠️ High Risk

FEI: 3008686996 • Geumcheon, Seoul • SOUTH KOREA

FEI

FEI Number

3008686996

📍

Location

Geumcheon, Seoul

🇰🇷
🏢

Address

Rm 501 Sj Techno Ville 278 Beotkkot-Ro, , Geumcheon, Seoul, South Korea

High Risk

FDA Import Risk Assessment

56.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

12
Total Refusals
4
Unique Violations
6/18/2025
Latest Refusal
12/21/2016
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
41.3×30%
Recency
74.6×20%
Frequency
14.1×10%
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

19711×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

4716×

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.

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.

Refusal History

DateProductViolationsDivision
6/18/2025
65LAJ11TITANIUM DIOXIDE (PROTECTANT)
118NOT LISTED
3280FRNMFGREG
Division of West Coast Imports (DWCI)
8/9/2018
53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
Division of West Coast Imports (DWCI)
8/9/2018
53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
Division of West Coast Imports (DWCI)
8/9/2018
53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
Division of West Coast Imports (DWCI)
8/9/2018
53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
Division of West Coast Imports (DWCI)
4/26/2017
53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
Division of West Coast Imports (DWCI)
12/21/2016
53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
12/21/2016
53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
12/21/2016
53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
12/21/2016
53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
12/21/2016
53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
12/21/2016
53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
471CSTIC LBLG
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Iaso, Inc.'s FDA import refusal history?

Iaso, Inc. (FEI: 3008686996) has 12 FDA import refusal record(s) in our database, spanning from 12/21/2016 to 6/18/2025.

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. Iaso, Inc.'s FEI number is 3008686996.

What types of violations has Iaso, Inc. received?

Iaso, Inc. has been cited for 4 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 Iaso, Inc. come from?

All FDA import refusal data for Iaso, Inc. 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.