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Manto

⚠️ Moderate Risk

FEI: 3011676669 • Gangwon-Do • SOUTH KOREA

FEI

FEI Number

3011676669

📍

Location

Gangwon-Do

🇰🇷
🏢

Address

Wonju Posco The-Sharp Art., Seogok-Ri, , Wonju-Si, Gangwon-Do, , South Korea

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/2/2015
Latest Refusal
9/2/2015
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

31201×

EPHEDALK

The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.

Refusal History

DateProductViolationsDivision
9/2/2015
54FBT09EPHEDRA (HERBAL & BOTANICALS, NOT TEAS)
3120EPHEDALK
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Manto's FDA import refusal history?

Manto (FEI: 3011676669) has 1 FDA import refusal record(s) in our database, spanning from 9/2/2015 to 9/2/2015.

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. Manto's FEI number is 3011676669.

What types of violations has Manto received?

Manto 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 Manto come from?

All FDA import refusal data for Manto 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.