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Wiston Herbs Enterprise

⚠️ Moderate Risk

FEI: 3009605787 • Penangpenang • MALAYSIA

FEI

FEI Number

3009605787

📍

Location

Penangpenang

🇲🇾

Country

MALAYSIA
🏢

Address

++95 Taman Gotthied, , Penangpenang, , Malaysia

Moderate Risk

FDA Import Risk Assessment

41.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
12/27/2012
Latest Refusal
9/7/2012
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
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

21201×

UNSFDIETSP

The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

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
12/27/2012
62EBR99ANTI-HYPOTENSIVE N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/7/2012
54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2120UNSFDIETSP
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Wiston Herbs Enterprise's FDA import refusal history?

Wiston Herbs Enterprise (FEI: 3009605787) has 2 FDA import refusal record(s) in our database, spanning from 9/7/2012 to 12/27/2012.

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. Wiston Herbs Enterprise's FEI number is 3009605787.

What types of violations has Wiston Herbs Enterprise received?

Wiston Herbs Enterprise 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 Wiston Herbs Enterprise come from?

All FDA import refusal data for Wiston Herbs Enterprise 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.