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Suthera Enterprise Co,.Ltd

⚠️ Moderate Risk

FEI: 3007996820 • Tha Muang, Kanchanaburi • THAILAND

FEI

FEI Number

3007996820

📍

Location

Tha Muang, Kanchanaburi

🇹🇭

Country

THAILAND
🏢

Address

Wangkanai Thamuang, 299 Moo 3 New Sangchuto Rd., Tha Muang, Kanchanaburi, Thailand

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
10/29/2012
Latest Refusal
10/29/2012
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
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

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

2741×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

641×

YELLOW #5

The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.

Refusal History

DateProductViolationsDivision
10/29/2012
03MGN99COOKIE,BISCUIT,WAFER DOUGH, N.E.C.
11UNSAFE COL
274COLOR LBLG
64YELLOW #5
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Suthera Enterprise Co,.Ltd's FDA import refusal history?

Suthera Enterprise Co,.Ltd (FEI: 3007996820) has 1 FDA import refusal record(s) in our database, spanning from 10/29/2012 to 10/29/2012.

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. Suthera Enterprise Co,.Ltd's FEI number is 3007996820.

What types of violations has Suthera Enterprise Co,.Ltd received?

Suthera Enterprise Co,.Ltd has been cited for 3 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 Suthera Enterprise Co,.Ltd come from?

All FDA import refusal data for Suthera Enterprise 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.