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Sou Chang

Low Risk

FEI: 3010062033 • Ventiane, Ventiane Capital • LAOS

FEI

FEI Number

3010062033

📍

Location

Ventiane, Ventiane Capital

🇱🇦

Country

LAOS
🏢

Address

Nong Song Hong, , Ventiane, Ventiane Capital, Laos

Low Risk

FDA Import Risk Assessment

21.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
2
Unique Violations
4/3/2013
Latest Refusal
4/3/2013
Earliest Refusal

Score Breakdown

Violation Severity
35.0×40%
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

2561×

INCONSPICU

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
4/3/2013
54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
473LABELING
Cincinnati District Office (CIN-DO)
4/3/2013
54EBY99HERBALS & BOTANICAL TEAS, N.E.C.
256INCONSPICU
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Sou Chang's FDA import refusal history?

Sou Chang (FEI: 3010062033) has 2 FDA import refusal record(s) in our database, spanning from 4/3/2013 to 4/3/2013.

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. Sou Chang's FEI number is 3010062033.

What types of violations has Sou Chang received?

Sou Chang 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 Sou Chang come from?

All FDA import refusal data for Sou Chang 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.