ImportRefusal LogoImportRefusal

Magna Circle Sdn Bhd

⚠️ Moderate Risk

FEI: 3009874052 • Shah Alam, Selangor • MALAYSIA

FEI

FEI Number

3009874052

📍

Location

Shah Alam, Selangor

🇲🇾

Country

MALAYSIA
🏢

Address

Subang, 6g Jalan Suria Ru 5/R, Shah Alam, Selangor, Malaysia

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
4/23/2014
Latest Refusal
4/23/2014
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
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

23001×

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.

33001×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

36811×

NCONTACTS

The product is a dietary supplement that is marketed in the United States and appears to not have a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event.

Refusal History

DateProductViolationsDivision
4/23/2014
54HBL04FISH OIL (FATS AND LIPID SUBSTANCES)
2300DIETARYLBL
3300ALLERGEN
3681NCONTACTS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Magna Circle Sdn Bhd's FDA import refusal history?

Magna Circle Sdn Bhd (FEI: 3009874052) has 1 FDA import refusal record(s) in our database, spanning from 4/23/2014 to 4/23/2014.

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. Magna Circle Sdn Bhd's FEI number is 3009874052.

What types of violations has Magna Circle Sdn Bhd received?

Magna Circle Sdn Bhd 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 Magna Circle Sdn Bhd come from?

All FDA import refusal data for Magna Circle Sdn Bhd 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.