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Chang'S Culture Enterprise Co. Ltd.

⚠️ Moderate Risk

FEI: 3003912486 • Taipei • TAIWAN

FEI

FEI Number

3003912486

📍

Location

Taipei

🇹🇼

Country

TAIWAN
🏢

Address

3 Tien Mu W. Road, , Taipei, , Taiwan

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
12/30/2003
Latest Refusal
12/30/2003
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
12/30/2003
54FAH99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Chang'S Culture Enterprise Co. Ltd.'s FDA import refusal history?

Chang'S Culture Enterprise Co. Ltd. (FEI: 3003912486) has 1 FDA import refusal record(s) in our database, spanning from 12/30/2003 to 12/30/2003.

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. Chang'S Culture Enterprise Co. Ltd.'s FEI number is 3003912486.

What types of violations has Chang'S Culture Enterprise Co. Ltd. received?

Chang'S Culture Enterprise Co. Ltd. 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 Chang'S Culture Enterprise Co. Ltd. come from?

All FDA import refusal data for Chang'S Culture Enterprise Co. Ltd. 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.