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Luen Fook Medicine Sdn. Bhd.

⚠️ Moderate Risk

FEI: 3001321832 • Johor Bahru, Johor • MALAYSIA

FEI

FEI Number

3001321832

📍

Location

Johor Bahru, Johor

🇲🇾

Country

MALAYSIA
🏢

Address

Taman Periindustrian Sri Plentong, No 6 Jalan Sri Plentong 5, Johor Bahru, Johor, Malaysia

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/1/2011
Latest Refusal
6/14/2010
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
4/1/2011
62UBL99ANTI-TUSSIVE/COLD N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
6/14/2010
64HBL99EXPECTORANT N.E.C.
75UNAPPROVED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Luen Fook Medicine Sdn. Bhd.'s FDA import refusal history?

Luen Fook Medicine Sdn. Bhd. (FEI: 3001321832) has 2 FDA import refusal record(s) in our database, spanning from 6/14/2010 to 4/1/2011.

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. Luen Fook Medicine Sdn. Bhd.'s FEI number is 3001321832.

What types of violations has Luen Fook Medicine Sdn. Bhd. received?

Luen Fook Medicine 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 Luen Fook Medicine Sdn. Bhd. come from?

All FDA import refusal data for Luen Fook Medicine 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.