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PureCircle Sdn Bhd

⚠️ Moderate Risk

FEI: 3006977150 • Banda Enstek, Negeri Sembilan • MALAYSIA

FEI

FEI Number

3006977150

📍

Location

Banda Enstek, Negeri Sembilan

🇲🇾

Country

MALAYSIA
🏢

Address

Pt23419, Lengkuk Teknologi, Negeri Sembilan, Malaysia, Banda Enstek, Negeri Sembilan, Malaysia

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/30/2014
Latest Refusal
4/30/2014
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

2381×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

3201×

LACKS FIRM

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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
4/30/2014
45TY99ALL OTHER PRODUCTS, NON-NUTRITIVE SWEETENERS
238UNSAFE ADD
320LACKS FIRM
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is PureCircle Sdn Bhd's FDA import refusal history?

PureCircle Sdn Bhd (FEI: 3006977150) has 1 FDA import refusal record(s) in our database, spanning from 4/30/2014 to 4/30/2014.

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. PureCircle Sdn Bhd's FEI number is 3006977150.

What types of violations has PureCircle Sdn Bhd received?

PureCircle Sdn Bhd 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 PureCircle Sdn Bhd come from?

All FDA import refusal data for PureCircle 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.