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Five Leaf Co Ltd

⚠️ Moderate Risk

FEI: 3004359395 • Mueang Chiang Mai, Chiang Mai • THAILAND

FEI

FEI Number

3004359395

📍

Location

Mueang Chiang Mai, Chiang Mai

🇹🇭

Country

THAILAND
🏢

Address

Soi 1 Alley Siritorn Road, , Mueang Chiang Mai, Chiang Mai, Thailand

Moderate Risk

FDA Import Risk Assessment

30.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
8/17/2004
Latest Refusal
8/17/2004
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

23002×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

751×

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
8/17/2004
54ECY99HERBALS & BOTANICAL TEAS, N.E.C.
2300DIETARYLBL
75UNAPPROVED
Seattle District Office (SEA-DO)
8/17/2004
52BYQ05FOOD PACKAGING MATERIAL (FOOD RELATED)
2300DIETARYLBL
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Five Leaf Co Ltd's FDA import refusal history?

Five Leaf Co Ltd (FEI: 3004359395) has 2 FDA import refusal record(s) in our database, spanning from 8/17/2004 to 8/17/2004.

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. Five Leaf Co Ltd's FEI number is 3004359395.

What types of violations has Five Leaf Co Ltd received?

Five Leaf 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 Five Leaf Co Ltd come from?

All FDA import refusal data for Five Leaf 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.