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Besfomec Industries Sdn Bhd

⚠️ Moderate Risk

FEI: 3006793177 • Alor Gajah, MY-04 • MALAYSIA

FEI

FEI Number

3006793177

📍

Location

Alor Gajah, MY-04

🇲🇾

Country

MALAYSIA
🏢

Address

Lot 1, Kawasan Perindustrian, , Alor Gajah, MY-04, Malaysia

Moderate Risk

FDA Import Risk Assessment

41.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
1/30/2008
Latest Refusal
1/30/2008
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

623×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

833×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
1/30/2008
29YCE99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
1/30/2008
29YCE99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
1/30/2008
29YCE99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Besfomec Industries Sdn Bhd's FDA import refusal history?

Besfomec Industries Sdn Bhd (FEI: 3006793177) has 3 FDA import refusal record(s) in our database, spanning from 1/30/2008 to 1/30/2008.

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. Besfomec Industries Sdn Bhd's FEI number is 3006793177.

What types of violations has Besfomec Industries Sdn Bhd received?

Besfomec Industries 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 Besfomec Industries Sdn Bhd come from?

All FDA import refusal data for Besfomec Industries 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.