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Wei Mei Li Chemical Mfg Co Ltd

⚠️ Moderate Risk

FEI: 1000192594 • Taipei • TAIWAN

FEI

FEI Number

1000192594

📍

Location

Taipei

🇹🇼

Country

TAIWAN
🏢

Address

No 31 Lin Shin Sthsi Chih Town, , Taipei, , Taiwan

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
11/3/2009
Latest Refusal
11/3/2009
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

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).

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

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
11/3/2009
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
483DRUG NAME
San Francisco District Office (SAN-DO)
11/3/2009
66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Wei Mei Li Chemical Mfg Co Ltd's FDA import refusal history?

Wei Mei Li Chemical Mfg Co Ltd (FEI: 1000192594) has 2 FDA import refusal record(s) in our database, spanning from 11/3/2009 to 11/3/2009.

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. Wei Mei Li Chemical Mfg Co Ltd's FEI number is 1000192594.

What types of violations has Wei Mei Li Chemical Mfg Co Ltd received?

Wei Mei Li Chemical Mfg Co Ltd has been cited for 3 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 Wei Mei Li Chemical Mfg Co Ltd come from?

All FDA import refusal data for Wei Mei Li Chemical Mfg 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.