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Ckl Tongkat Ali Center Sdn Bhd

⚠️ Moderate Risk

FEI: 3005154574 • Selangor • MALAYSIA

FEI

FEI Number

3005154574

📍

Location

Selangor

🇲🇾

Country

MALAYSIA
🏢

Address

10 Jin S.B. Jaya 11, Tmn. Industries, , Selangor, , Malaysia

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/23/2006
Latest Refusal
2/23/2006
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
2/23/2006
60EIR99ADRENOCORTICAL SUPPRESSANT N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Ckl Tongkat Ali Center Sdn Bhd's FDA import refusal history?

Ckl Tongkat Ali Center Sdn Bhd (FEI: 3005154574) has 1 FDA import refusal record(s) in our database, spanning from 2/23/2006 to 2/23/2006.

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. Ckl Tongkat Ali Center Sdn Bhd's FEI number is 3005154574.

What types of violations has Ckl Tongkat Ali Center Sdn Bhd received?

Ckl Tongkat Ali Center 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 Ckl Tongkat Ali Center Sdn Bhd come from?

All FDA import refusal data for Ckl Tongkat Ali Center 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.