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Lucky Enzyme Bio Tech Inc

⚠️ Moderate Risk

FEI: 3004423359 • Taipei • TAIWAN

FEI

FEI Number

3004423359

📍

Location

Taipei

🇹🇼

Country

TAIWAN
🏢

Address

3f-24 No.97 Sec.4 Chung Hsiao E. Rd, , Taipei, , Taiwan

Moderate Risk

FDA Import Risk Assessment

28.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
6/8/2004
Latest Refusal
6/8/2004
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1182×

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).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
6/8/2004
54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
473LABELING
Los Angeles District Office (LOS-DO)
6/8/2004
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
6/8/2004
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Lucky Enzyme Bio Tech Inc's FDA import refusal history?

Lucky Enzyme Bio Tech Inc (FEI: 3004423359) has 3 FDA import refusal record(s) in our database, spanning from 6/8/2004 to 6/8/2004.

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. Lucky Enzyme Bio Tech Inc's FEI number is 3004423359.

What types of violations has Lucky Enzyme Bio Tech Inc received?

Lucky Enzyme Bio Tech Inc 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 Lucky Enzyme Bio Tech Inc come from?

All FDA import refusal data for Lucky Enzyme Bio Tech Inc 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.