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Biofact Life Sdn Bhd

⚠️ Moderate Risk

FEI: 3007811222 • Mua Johorpur • MALAYSIA

FEI

FEI Number

3007811222

📍

Location

Mua Johorpur

🇲🇾

Country

MALAYSIA
🏢

Address

Lot 5094 Kawasan Preindustrian P, , Mua Johorpur, , Malaysia

Moderate Risk

FDA Import Risk Assessment

25.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/5/2023
Latest Refusal
1/5/2023
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
25.6×20%
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

2181×

LIST INGRE

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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
1/5/2023
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
218LIST INGRE
482NUTRIT LBL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Biofact Life Sdn Bhd's FDA import refusal history?

Biofact Life Sdn Bhd (FEI: 3007811222) has 1 FDA import refusal record(s) in our database, spanning from 1/5/2023 to 1/5/2023.

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. Biofact Life Sdn Bhd's FEI number is 3007811222.

What types of violations has Biofact Life Sdn Bhd received?

Biofact Life 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 Biofact Life Sdn Bhd come from?

All FDA import refusal data for Biofact Life 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.