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Organo Gold Malaysia Sdn Bhd

⚠️ Moderate Risk

FEI: 3010685863 • Selangor • MALAYSIA

FEI

FEI Number

3010685863

📍

Location

Selangor

🇲🇾

Country

MALAYSIA
🏢

Address

Mezzanine Floor The Crest Datara, , Selangor, , Malaysia

Moderate Risk

FDA Import Risk Assessment

27.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
11/6/2015
Latest Refusal
11/6/2015
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

4824×

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
11/6/2015
30YYY99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
482NUTRIT LBL
Cincinnati District Office (CIN-DO)
11/6/2015
30YYY99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
482NUTRIT LBL
Cincinnati District Office (CIN-DO)
11/6/2015
31ADY99COFFEE, N.E.C.
482NUTRIT LBL
Cincinnati District Office (CIN-DO)
11/6/2015
31ADY99COFFEE, N.E.C.
482NUTRIT LBL
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Organo Gold Malaysia Sdn Bhd's FDA import refusal history?

Organo Gold Malaysia Sdn Bhd (FEI: 3010685863) has 4 FDA import refusal record(s) in our database, spanning from 11/6/2015 to 11/6/2015.

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. Organo Gold Malaysia Sdn Bhd's FEI number is 3010685863.

What types of violations has Organo Gold Malaysia Sdn Bhd received?

Organo Gold Malaysia Sdn Bhd has been cited for 1 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 Organo Gold Malaysia Sdn Bhd come from?

All FDA import refusal data for Organo Gold Malaysia 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.