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Euoko Inc

⚠️ Moderate Risk

FEI: 3008353190 • Toronto, ON • CANADA

FEI

FEI Number

3008353190

📍

Location

Toronto, ON

🇨🇦

Country

CANADA
🏢

Address

535-67 Mowat Ave, , Toronto, ON, Canada

Moderate Risk

FDA Import Risk Assessment

28.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
1/7/2012
Latest Refusal
1/7/2012
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
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

1182×

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).

4711×

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
1/7/2012
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
New Orleans District Office (NOL-DO)
1/7/2012
63VBL99DEPIGMENTOR N.E.C.
118NOT LISTED
New Orleans District Office (NOL-DO)
1/7/2012
65LBL99PROTECTANT N.E.C.
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Euoko Inc's FDA import refusal history?

Euoko Inc (FEI: 3008353190) has 3 FDA import refusal record(s) in our database, spanning from 1/7/2012 to 1/7/2012.

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. Euoko Inc's FEI number is 3008353190.

What types of violations has Euoko Inc received?

Euoko Inc 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 Euoko Inc come from?

All FDA import refusal data for Euoko 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.